Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
397
Countries
10
Sites
39
Relapsed and Lenalidomide-Refractory Multiple Myeloma
To compare the efficacy of cilta-cel with standard therapy, either PVd or DPd
Key facts
- Sponsor
- Janssen - Cilag International
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 12 Jun 2020 → ongoing
- Decision date (initial)
- 2024-04-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506588-32-00
- EudraCT number
- 2019-001413-16
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety, Pharmacokinetic, Therapy, Others, Efficacy
To compare the efficacy of cilta-cel with standard therapy, either PVd or DPd
Conditions and MedDRA coding
Relapsed and Lenalidomide-Refractory Multiple Myeloma
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Be at least 18 years of age.
- Have documented diagnosis of MM as defined by the criteria below:-Multiple myeloma diagnosis according to the IMWG diagnostic criteria -Measurable disease at screening
- Have received 1 to 3 prior lines of therapy including a PI and IMiD. Subject must have undergone at least 1 complete cycle of treatment for each line of therapy, unless PD was the best response to the line of therapy
- Have documented evidence of PD by IMWG criteria based on investigator's determination on or within 6 months of their last regimen.
- Subjects with only 1 prior line of therapy must have progressed within 36 months of a stem cell transplant or if not transplanted, then within 42 months of starting initial therapy.
- Be refractory to lenalidomide per IMWG consensus guidelines in at least one prior line of therapy.
- Have an ECOG Performance Status score of 0 or 1
- Have clinical laboratory values as specified in the protocol. For additional information see section 5.1 of the protocol
Exclusion criteria 12
- Prior treatment with CAR-T therapy directed at any target.
- Any previous therapy that is targeted to BCMA.
- Ongoing toxicity from previous anticancer therapy that has not resolved to baseline levels or to Grade 1 or less; except for alopecia.
- Subjects with ongoing peripheral neuropathy may be limited to DPd as standard therapy or bridging therapy
- Was vaccinated with live attenuated vaccines within 6 weeks prior to randomization
- Subject received any antitumor therapy as specified in the protocol, prior to randomization
- Active malignancies other than the disease being treated under study. Refer to the protocol for allowed exceptions.
- Plasma cell leukemia at the time of screening, Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis.
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to cilta-cel or its excipients, including dimethylsulfoxide, or to fludarabine, cyclophosphamide, tocilizumab, pomalidomide, dexamethasone.- Subjects with contraindications or life-threatening allergies, hypersensitivity, or intolerance to daratumumab will not be permitted to receive DPd as standard therapy or bridging therapy; however, subjects may receive PVd as standard therapy or bridging therapy. Likewise, subjects with contraindications or life-threatening allergies, hypersensitivity, or intolerance to bortezomib will not be permitted to receive PVd as standard therapy or bridging therapy; but may receive DPd as standard therapy or bridging therapy.
- Stroke or seizure within 6 months of signing ICF.
- Received either of the following:-An allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must have stopped all immunosuppressive medications for 6 weeks without signs of graftversus-host disease. Subjects with active graft-versus-host disease are excluded.-An autologous stem cell transplantation ≤ 12 weeks before apheresis.
- Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of MM. For additional information, see section 5.2 of the protocol
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-free survival (PFS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
CARVYKTI 3.2 × 10^6 – 1.0 × 10^8 cells dispersion for infusion
PRD9718535 · Product
- Active substance
- Ciltacabtagene Autoleucel
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 kg kilogram(s)
- Max total dose
- 0 kg kilogram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XL05 — -
- Marketing authorisation
- EU/1/22/1648/001
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/20/2252
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical trial will be conducted with "clinical" material. Compared to the authorized product, the same CAR-T drug product manufacturing process is used. For the lentiviral vector process, the only difference is that the lentiviral vector manufacturing process may differ from the authorized product, e.g. the adherent process instead of the suspension process.
Comparator 17
PRD9260808 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/004
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/672
- Modified vs. Marketing Authorisation
- No
PRD9260805 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/672
- Modified vs. Marketing Authorisation
- No
PRD9260813 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/007
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/672
- Modified vs. Marketing Authorisation
- No
PRD9260809 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/005
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/672
- Modified vs. Marketing Authorisation
- No
PRD9260804 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/672
- Modified vs. Marketing Authorisation
- No
PRD9260810 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/006
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/672
- Modified vs. Marketing Authorisation
- No
PRD9260806 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/672
- Modified vs. Marketing Authorisation
- No
PRD9260814 · Product
- Active substance
- Pomalidomide
- Substance synonyms
- CC-4047
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L04AX06 — -
- Marketing authorisation
- EU/1/13/850/008
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/672
- Modified vs. Marketing Authorisation
- No
PRD988426 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 40153.00.00
- MA holder
- MIBE GMBH ARZNEIMITTEL
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Tablets BP 2.0mg
PRD3570594 · Product
- Active substance
- Dexamethasone Ph. Eur.
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PL 39699/0056
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP13241261 · ATC
- Active substance
- Bortezomib
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX32 — BORTEZOMIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD11001952 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11001954 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11001953 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD11001955 · Product
- Active substance
- Pomalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- JANSSEN-CILAG INTERNATIONAL N.V.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10324898 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 4865 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 9587.01.00
- MA holder
- MERCK HEALTHCARE GERMANY GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
DARZALEX 1800 mg solution for injection
PRD8157846 · Product
- Active substance
- Daratumumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 78 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FC01 — -
- Marketing authorisation
- EU/1/16/1101/004
- MA holder
- JANSSEN-CILAG INTERNATIONAL NV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/13/1153
- Modified vs. Marketing Authorisation
- No
Auxiliary 2
SCP130444 · ATC
- Active substance
- Cyclophosphamide
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/m2 milligram(s)/square meter
- Max total dose
- 0 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP146752 · ATC
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/m2 milligram(s)/square meter
- Max total dose
- 0 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Janssen - Cilag International
- Sponsor organisation
- Janssen - Cilag International
- Address
- Turnhoutseweg 30
- City
- Beerse
- Postcode
- 2340
- Country
- Belgium
Scientific contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Public contact point
- Organisation
- Janssen - Cilag International
- Contact name
- CTIS Point of Contact
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Ancillare LP ORG-100044089
|
Horsham, United States | Other |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Pharmaceutical Product Development LLC ORG-100016999
|
Wilmington, United States | Data management |
| Cerba Research ORG-100042694
|
Gent, Belgium | Laboratory analysis |
| Hematogenix Laboratory Services Limited ORG-100047188
|
Cheadle, United Kingdom | Laboratory analysis |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Data management |
| CMT Cellex Manufacturing Transports and Logistics GmbH ORG-100026399
|
Cologne, Germany | Laboratory analysis |
| Laboratory Corporation Of America Holdings ORG-100041800
|
Los Angeles, United States | Laboratory analysis |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| Signant Health LLC ORG-100040732
|
Blue Bell, United States | Interactive response technologies (IRT) |
Locations
10 EU/EEA countries · 39 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 15 | 4 |
| Denmark | Ongoing, recruitment ended | 4 | 1 |
| France | Ongoing, recruitment ended | 34 | 6 |
| Germany | Ongoing, recruitment ended | 11 | 5 |
| Greece | Ended | 1 | 1 |
| Italy | Ongoing, recruitment ended | 33 | 5 |
| Netherlands | Ongoing, recruitment ended | 23 | 4 |
| Poland | Ongoing, recruitment ended | 24 | 4 |
| Spain | Ongoing, recruitment ended | 82 | 7 |
| Sweden | Ongoing, recruitment ended | 6 | 2 |
| Rest of world
Japan, Korea, Republic of, Israel, Australia, United States, United Kingdom
|
— | 164 | — |
Investigational sites
Universiteit Gent
Hematologie, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Hematologie, Herestraat 49, 3000, Leuven
Antwerp University Hospital
Hematologie, Drie Eikenstraat 655, 2650, Edegem
CHU De Liege
Hematologie, Avenue De L'hopital 1, 4000, Liege
Rigshospitalet
Dept of Hematology/Clinical trial unit 2081, Blegdamsvej 9, 2100, Copenhagen Oe
Hospices Civils De Lyon
Centre Hospitalier Lyon Sud - Service d’Hématologie Clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Assistance Publique Hopitaux De Paris
Hôpital Saint-Louis Service Immuno-hématologie, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Nantes
Service hématologie, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Lille
Hopital Huriez - Service Hématologie, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire De Toulouse
Service hématologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Centre Hospitalier Universitaire De Poitiers
Service d'Hématologie et Thérapie Cellulaire, Pôle Régional de Cancérologie, 2 Rue De La Miletrie, 86000, Poitiers
University Hospital Cologne AöR
Klinik 1 Innere Medizin, Studienzentrum Haematologie, Onkologie, Kerpener Strasse 62, Lindenthal, Cologne
Technische Universitat Dresden
Med. Klinik und Poliklinik 1, Haematologische Ambulanz MK1-A1, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II, Abt. fuer Onkologie, Haematologie, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Tuebingen AöR
Abt. fuer Innere Medizin II, Haematologie, Onkologie, Rheumatologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Universitaet Leipzig
Med. Klinik und Poliklinik I - Bereich Haematologie, Zelltherapie, Internistische Onkologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
University General Hospital Attikon
2nd Dept of Internal Medicine, Division of Hematology, Rimini Street 1, 124 62, Athens
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento Malattie Oncologiche ed Ematologiche, Via Pietro Albertoni 15, 40138, Bologna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Ematologia, Largo Francesco Vito 1, 00168, Rome
Fondazione IRCCS Istituto Nazionale Dei Tumori
Dipartimento di Oncologia Medica ed Ematologia - SC Ematologia, Via Giacomo Venezian 1, 20133, Milan
Ospedale San Raffaele S.r.l.
Dipartimento Onco-emtaologia Unità di Ematologia e Trapianto Midollo Osseo, Via Olgettina 60, 20132, Milan
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Dipartimento Biotecnologie Molecolari e Scienze per la Salute-SC Ematologia U-Università Torino, Corso Bramante 88, 10126, Turin
Universitair Medisch Centrum Groningen
Hematologie, Hanzeplein 1, 9713 GZ, Groningen
Amsterdam UMC
Hematologie, De Boelelaan 1117, 1081 HV, Amsterdam
Universitair Medisch Centrum Utrecht
Hematologie, Heidelberglaan 100, 3584 CX, Utrecht
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hematologie, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Hematology, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Instytut Hematologii I Transfuzjologii
Hematology, Ul Indiry Gandhi 14, 02-776, Warsaw
Uniwersytecki Szpital Kliniczny W Poznaniu
Hematology, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Uniwersyteckie Centrum Kliniczne
Hematology, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Hospital Universitario 12 De Octubre
Hematology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Clinica Universidad De Navarra
Hematology, Avenue Pio XII 36, 31008, Pamplona
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2020-06-15 | 2020-06-30 | 2021-09-23 | ||
| Denmark | 2020-11-05 | 2020-12-07 | 2021-09-21 | ||
| France | 2021-01-26 | 2021-02-04 | 2021-10-26 | ||
| Germany | 2021-04-30 | 2021-05-03 | 2021-10-05 | ||
| Greece | 2021-09-08 | 2025-06-24 | 2021-09-23 | 2021-10-06 | |
| Italy | 2020-11-05 | 2020-11-18 | 2021-10-20 | ||
| Netherlands | 2020-09-24 | 2020-10-07 | 2021-09-30 | ||
| Poland | 2020-11-18 | 2020-12-29 | 2021-09-30 | ||
| Spain | 2020-06-12 | 2020-06-30 | 2021-10-20 | ||
| Sweden | 2021-02-17 | 2021-04-22 | 2021-09-28 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Unexpected events 2 · Art. 53 CTR
Note: SUSARs are reported via EudraVigilance, not CTIS — events shown here are CTIS-public notifications only.
Unexpected event UE-113521
- Event date
- 2025-12-22
- Date aware
- 2025-12-22
- Submission date
- 2026-01-06
- Member states affected
- Belgium, Denmark, France, Germany, Greece, Italy, Spain, Sweden, Netherlands, Poland
- Clinical procedures
- Exceptional release for JNJ-68284528 Drug Product (DP) - Dosing Administration
- Event description
- Out of Specification administration: Manufacturing of JNJ-68284528 DP for Subject O30NL10004005 (Batch QJGS0H2 ) was performed at the Janssen DP manufacturing facility in Techlane, Ghent, Belgium. An out of specification (OOS) result: OOS IFNγ Secretion Potency Assay result: 2,415 pg/mL
Specifications IFNγ Secretion Potency Assay: 2616-85,000 pg/mL
All other drug product quality attributes met the specification.
Unexpected event UE-114379
- Event date
- 2025-12-29
- Date aware
- 2025-12-29
- Submission date
- 2026-01-13
- Member states affected
- Belgium, Denmark, France, Germany, Greece, Italy, Spain, Sweden, Netherlands, Poland
- Clinical procedures
- Exceptional release for JNJ-68284528 Drug Product (DP) - Dosing Administration
- Event description
- Out of Specification administration: Manufacturing of JNJ-68284528 DP for Subject O30NL10002002 (Batch QJGS0IX ) was performed at the Janssen DP manufacturing facility in Techlane, Ghent, Belgium. An out of specification (OOS) result: 0.4 x 10^6 CAR+ viable T cells/kg
Specification of Dose: 0.5-1.0 x 10^6 CAR+ viable T cells/kg
All other drug product quality attributes met the specification.
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 137 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_REDACTED Protocol 2023-506588-32 | Am6_EEA-2 |
| Protocol (for publication) | REDACTED_D1_Protocol_EL_2023-506588-32 | Am4 EEA-1 |
| Protocol (for publication) | REDACTED_D4 PF Temp Diary Crossover_NL_dut_2023-506588-32 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Temp Diary Crossover_BE_dut_2023-506588-32 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Temp Diary Crossover_BE_fre_2023-506588-32 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Temp Diary Crossover_DE_ger_2023-506588-32 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Temp Diary Crossover_DK_dan_2023-506588-32 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Temp Diary Crossover_ES_spa_2023-506588-32 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Temp Diary Crossover_FR_fre_2023-506588-32 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Temp Diary Crossover_GR_gre_2023-506588-32 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Temp Diary Crossover_IT_ita_2023-506588-32 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Temp Diary Crossover_PL_pol_2023-506588-32 | 3 |
| Protocol (for publication) | REDACTED_D4_PF Temp Diary Crossover_SE_swe_2023-506588-32 | 3 |
| Recruitment arrangements (for publication) | K1_Placeholder Document_ Recruitment Arrangements_GRC_ENG_68284528MMY3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder Document_Recruitment Arrangement_DE_ENG_68284528MMY3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder document_Recruitment Arrangements_FR_EN_68284528MMY3002 | 1 |
| Recruitment arrangements (for publication) | K1_PLACEHOLDER_Recruitment arrangement_DK_eng_68284528MMY3002 | 1 |
| Recruitment arrangements (for publication) | K1_PLACEHOLDER_Recruitment arrangement_SE_eng_68284528MMY3002 | 1 |
| Recruitment arrangements (for publication) | K1_Placeholder_Recruitment Arrangements_PL_EN_68284528MMY3002 | 1 |
| Recruitment arrangements (for publication) | K2_Placeholder_Advertisement and recruitment materials_IT_ENG_68284528MMY3002 | 1 |
| Recruitment arrangements (for publication) | K2_Placeholder_Recruitment Arrangement-ICF Procedure Declaration_IT_ENG_68284528MMY3002 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER K1_Recruitment Arrangements_BE_Eng_68284528MMY3002 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER_K1_Recruitment Arrangements _ES_EN_68284528MMY3002 | 1 |
| Recruitment arrangements (for publication) | PLACEHOLDER_K1_Recruitment arrangements_NL_Eng_68284528MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_Addendum to Main ICF_GRC_GRC_68284528MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_ICF OOS Addendum_BE_Eng_68284528MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_ICF_BE_Eng_68284528MMY3002 | 8.2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_PP ICF_GRC_GRC_68284528MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 1 to Clinical 9_PL_POL_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 2 to Main ICF_PL_PL_68284528MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 3_BE_Dut_2023-506588-32 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 3_BE_Fre_2023-506588-32 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 3_NL_Dut_2023-506588-32 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 4_BE_Dut_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 4_BE_Fre_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum 4_NL_Dut_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum ARM B safety and Data privacy_FR_FR_68284528MMY3002 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF addendum Clinical_SE_Swe_2023-506588-32 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum COVID-19 and Eye effects_FR_FR_68284528MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum Crossover_FR_FRE_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum Crossover_PL_POL_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum Data privacy_FR_FR_68284528MMY3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum Main_FR_FRE_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum OOS_PL_POL_2023-506588-32 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum Out of specification_FR_FRE_2023-506588-32 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum REGIMEN B safety_FR_FR_68284528MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum to Crossover_SE_SWE_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Addendum to Main_DK_DAN_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical addendum_ES_SPA_2023-506588-32 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical Addendum_IT_ITA_2023-506588-32 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical Crossover_DE_ger_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical ICF_ES_ES_68284528MMY3002 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_DK_dan_2023-506588-32 | 13 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_PL_POL_2023-506588-32 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Clinical_SE_Swe_2023-506588-32 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Cross Over_FR_FRE_2023-506588-32 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Crossover_BE_Dut_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Crossover_BE_Fre_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Crossover_DK_dan_2023-506588-32 | V2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Crossover_ES_SPA_2023-506588-32 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Crossover_IT_ITA_2023-506588-32 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Crossover_NL_Dut_2023-506588-32 | 3.1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Crossover_PL_POL_2023-506588-32 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Crossover_SE_Swe_2023-506588-32 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main addendum_DE_GER_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main Study_GR_gre_2023-506588-32 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Dut_2023-506588-32 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_BE_Fre_2023-506588-32 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Main_FR_FR_68284528MMY3002 | 15 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Addendum_DK_dan_2023-506588-32 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Addendum_ES_SPA_2023-506588-32 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Addendum_GR_gre_2023-506588-32-00 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master Addendum_SE _swe_2023-506588-32 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Master ICF Addendum 3_PL_POL_2023-506588-32 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OOS Addendum 2_BE_Dut_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OOS Addendum 2_BE_Fre_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF OOS Addendum 2_NL_Dut_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Compatible Research_DK_dan_2023-506588-32 | V1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Optional Sample_DK_dan_2023-506588-32 | V5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_Consent_Form_PL_PL_68284528MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_ES_ES_68284528MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_FR_FR_68284528MMY3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Partner_IT_ITA_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Pregnant Patient_ES_ES_68284528MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Family_IT_ITA_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Privacy Pregnant Partner_IT_ITA_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_Consent_Form_PL_PL_68284528MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF Withdrawal_ES_ES_68284528MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum 5 Arm A_FR_FRE_ 2023-506588-32 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum 5 Arm B_FR_FRE_ 2023-506588-32 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum Clinical ICF_IT_ITA_2023-506588-32 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Addendum OOS_DE_ger_2023-506588-32 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Attachment 1 to Clinical ICF_IT_ITA_68284528MMY3002 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Attachment 2 to Clinical ICF_IT_ITA_68284528MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Clinical ICF_IT_ITA_68284528MMY3002 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Clinical main ICF_DE_GER_68284528MMY3002 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_MAIN_NL_Dut_68284528MMY3002 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Optional further research ICF_DE_GER_68284528MMY3002 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Patient Travel Reimbursement_IT_ITA_2023-506588-32 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Pregnant partner consent form_DE_GER_68284528MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Privacy Child Exposed to IP_IT_ITA_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_Privacy Clinical ICF_IT_ITA_68284528MMY3002 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L1_SIS and ICF_WIthdrawal ICF_IT_ITA_68284528MMY3002 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject wallet card Arm A_DE_GER_2023-506588-32 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm A_IT_ITA_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B - Crossover_IT_ITA_2023-506588-32 | 8 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Arm B_DE_ger_2023-506588-32 | 9 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Crossover_Arm B_SE_Swe_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Crossover_SE_Swe_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Group B Crossover_ES_SPA_2023-506588-32 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Group B_GR_gre_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Grupp A_SE_Swe_2023-506588-32 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card Grupp B_SE_Swe_2023-506588-32 | 4 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Arm A_FR_FRE_2023-506588-32 | 5 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Arm B_FR_FRE_2023-506588-32 | 10 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_CAR-T arm_DK_dan_2023-506588-32 | 7 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_Crossover_DK_dan_2023-506588-32 | 1 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_DPd or PVd arm_DK_dan_2023-506588-32 | 3 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_GR_gre_2023-506588-32-00 | 2 |
| Subject information and informed consent form (for publication) | REDACTED_L2_Subject Wallet Card_PL_POL_2023-506588-32 | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Dexamethasone 2mg Merck | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Pomalidomide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Pomalidomide | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Velcade | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Dexamethason_4mg | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Dexamethasone_2mg | NA |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_Dut_2023-506588-32 | Am6 EEA-2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_Fre_2023-506588-32 | Am6 EEA-2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_BE_Ger_2023-506588-32 | Am6 EEA-2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_ES_SPA_2023-506588-32 | AM6-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_FR_FRE_2023-506588-32 | Am6-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_GR_gre_2023-506588-32 | Am5-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_IT_ITA_2023-506588-32 | Am6-EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_NL_Dut_2023-506588-32 | Am6 EEA-2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol synopsis_NL_Eng_2023-506588-32 | Am 4 EEA-1 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_PL_POL_2023-506588-32 | Am6 EEA2 |
| Synopsis of the protocol (for publication) | REDACTED_D1_Protocol Synopsis_SE_SWE_2023-506588-32 | Am6-EEA2 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-13 | Belgium | Acceptable 2024-03-21
|
2024-03-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-31 | Belgium | Acceptable with conditions 2024-10-30
|
2024-10-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-06 | Belgium | Acceptable 2025-08-29
|
2025-08-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-12-01 | Belgium | Acceptable with conditions 2026-04-02
|
2026-04-02 |