A Phase 2, Open-Label, Multicenter, Basket Study Evaluating the Efficacy of Brexucabtagene Autoleucel in Adults with Rare B-cell Malignancies (ZUMA 25) – Substudy C – Relapsed/Refractory Burkitt Lymphoma (BL)

2022-501261-46-00 Protocol KT-US-568-0138-C Therapeutic exploratory (Phase II) Ended

Start 14 Apr 2023 · End 17 Dec 2024 · Status Ended · 7 EU/EEA countries · 14 sites · Protocol KT-US-568-0138-C

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Ended
Participants planned 33
Countries 7
Sites 14

Relapsed/Refractory Burkitt Lymphoma (BL)

The primary objective of ZUMA-25 is to evaluate the efficacy of brexucabtagene autoleucel in subjects with rare B-cell malignancies, by determining the Response Rates as defined within the substudies by central assessment. The primary objective of ZUMA-25 substudy C (BL) is to evaluate the efficacy of brexucabtagene au…

Key facts

Sponsor
Kite Pharma Inc.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Neoplasms [C04]
Trial duration
14 Apr 2023 → 17 Dec 2024
Decision date (initial)
2023-02-20
Transition trial
No
Low-intervention
No
Rare-disease indication
Yes
Vulnerable population
Yes
Funding sources
Kite Pharma Inc.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Pharmacokinetic, Safety, Therapy, Efficacy

The primary objective of ZUMA-25 is to evaluate the efficacy of brexucabtagene autoleucel in subjects with rare B-cell malignancies, by determining the Response Rates as defined within the substudies by central assessment. The primary objective of ZUMA-25 substudy C (BL) is to evaluate the efficacy of brexucabtagene autoleucel in subjects with BL, by determining the objective response rate (ORR) by central assessment

Secondary objectives 7

  1. The secondary objectives of ZUMA-25 as per the master protocol are: •To evaluate the Complete Response (CR) by central assessment as defined within each substudy.
  2. •Determine response durability
  3. •Determine survival status
  4. •Determine survival status without progression
  5. •Determine the time to next treatment (TTNT) after administration of brexucabtagene autoleucel
  6. •Determine the time to first response
  7. The Substudy C (BL) specific secondary objective is to evaluate the efficacy of brexucabtagene autoleucel in subjects with BL, by determining the ORR by investigator assessment

Conditions and MedDRA coding

Relapsed/Refractory Burkitt Lymphoma (BL)

Regulatory references

Scientific advice from competent authorities
Food And Drug Administration, European Medicines Agency
Plan to share IPD
No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

  1. •Male or female 18 years of age or older at the time of signing the informed consent
  2. •Presence of toxicities due to prior therapy must be stable and recovered to Grade 1 or lower
  3. •ECOG performance status score of 0 or 1.
  4. •Adequate hematologic and end-organ function.
  5. •Participants of childbearing potential who engage in heterosexual intercourse must agree to use specified method(s) of contraception
  6. • Histologically confirmed mature B-cell non-Hodgkin lymphoma (NHL) Burkitt lymphoma/leukemia.
  7. • Relapsed or refractory disease after first-line chemoimmunotherapy, defined as 1 of the following:
  8. • Refractory disease, defined as progressive disease or stable disease as best response to first-line therapy; individuals who are intolerant to first-line therapy are excluded.
  9. • Relapsed disease, defined as complete remission to first-line therapy followed by biopsy-proven disease relapse.
  10. • At least 1 measurable lesion based on the Lugano Classification. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.

Exclusion criteria 7

  1. •Prior CAR therapy or treatment with any anti-CD19 therapy
  2. •HIV-positive patients, unless taking appropriate anti-HIV medications, having an undetectable viral load by quantitative polymerase chain reaction (qPCR) and a CD4 count > 200 cells/uL
  3. •History or presence of detectable cerebrospinal fluid malignant cells or brain metastases, with the exception of prior CNS disease in WM
  4. •History of autoimmune disease (eg, Crohn’s disease, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years.
  5. • Burkitt-like lymphoma with 11q aberration, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangement, or high-grade B-cell lymphoma not otherwise specified.
  6. •Prior allogeneic stem cell transplant < 3 months prior to screening and/or <4 months prior to planned infusion of brexucabtagene autoleucel.
  7. •Presence of active graft-versus-host disease following prior allogeneic stem cell transplant.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary endpoint of ZUMA-25 as per the master protocol is response rates by central assessment as defined in each substudy. The primary end point of Substudy C (BL) is ORR, defined as the proportion of subjects who achieve a best response of either complete response (CR) or partial response (PR). Response will be determined by central assessment per the Lugano Classification.

Secondary endpoints 7

  1. The secondary endpoints of ZUMA-25 as per the master protocol are: • CR rate by central assessment as defined in each substudy
  2. • Duration of Response
  3. • Overall Survival
  4. • Progression-free survival
  5. • Time to next treatment defined as the time from enrollment (for Full Analysis Set [FAS]) or brexucabtagene autoleucel infusion (for modified intention to treat [mITT]) to the initiation of subsequent anticancer therapy/treatment
  6. • Time to first response from brexucabtagene autoleucel infusion to the first response as defined in the substudy
  7. The Substudy C (BL) specific secondary endpoint is ORR, defined as the proportion of subjects who achieve a best response of either CR or PR. Response will be determined by investigator assessment per the Lugano Classification

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Tecartus 0.4 – 2 × 108 cells dispersion for infusion

PRD8604659 · Product

Active substance
Brexucabtagene Autoleucel
Pharmaceutical form
DISPERSION FOR INFUSION
Route of administration
INTRAVENOUS INFUSION
Max daily dose
200000000 DF dosage form
Max total dose
200000000 DF dosage form
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
NOTASSIGN — -
Marketing authorisation
EU/1/20/1492/001
MA holder
KITE PHARMA EU B.V.
MA country
EU
Paediatric formulation
No
Orphan designation
Yes
Orphan designation number
EU/3/20/2344
Modified vs. Marketing Authorisation
No

Auxiliary 18

-

N02B · Product

Pharmaceutical form
-
Route of administration
ORAL
Max daily dose
1000 mg milligram(s)
Max total dose
1000 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
N02B — OTHER ANALGESICS AND ANTIPYRETICS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

—

SCP1712543 · ATC

Route of administration
INTRAVENOUS INFUSION
Max daily dose
50 mg/m2 milligram(s)/sq. meter
Max total dose
50 mg/m2 milligram(s)/sq. meter
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01DB01 — DOXORUBICIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Betamethasone Sodium Phosphate

SCP881751 · ATC

Active substance
Betamethasone Sodium Phosphate
Substance synonyms
BETAMETHASONE DISODIUM PHOSPHATE
Route of administration
ORAL
Max daily dose
120 mg/m2 milligram(s)/sq. meter
Max total dose
600 mg/m2 milligram(s)/sq. meter
Max treatment duration
5 Day(s)
Authorisation status
Authorised
ATC code
H02AB06 — PREDNISOLONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vinblastine Sulfate

SCP4338931 · ATC

Active substance
Vinblastine Sulfate
Substance synonyms
VINBLASTINE SULPHATE
Route of administration
INTRAVENOUS INFUSION
Max daily dose
2 mg milligram(s)
Max total dose
4 mg/Kg milligram(s)/kilogram
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01CA02 — VINCRISTINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Oxaliplatin

SCP1891954 · ATC

Active substance
Oxaliplatin
Route of administration
INTRAVENOUS INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
100 mg/m2 milligram(s)/sq. meter
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L01XA03 — OXALIPLATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

SCP45096310 · ATC

Active substance
Alpelisib
Substance synonyms
(2S)-N1-(4-METHYL-5-(1-(1,1,1-TRIFLUORO-2-METHYLPROPAN-2-YL)PYRIDIN-4-YL)-1,3-THIAZOL-2-YL)PYRROLIDINE-1,2-DICARBOXAMIDE, BYL719
Route of administration
ORAL
Max daily dose
400 mg milligram(s)
Max total dose
8800 mg milligram(s)
Max treatment duration
22 Day(s)
Authorisation status
Authorised
ATC code
L01XX — OTHER ANTINEOPLASTIC AGENTS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Etoposide

SCP6155697 · ATC

Active substance
Etoposide
Route of administration
INTRAVENOUS INFUSION
Max daily dose
100 mg/m2 milligram(s)/sq. meter
Max total dose
300 mg/m2 milligram(s)/sq. meter
Max treatment duration
4 Day(s)
Authorisation status
Authorised
ATC code
L01CB01 — ETOPOSIDE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

L04A · Product

Pharmaceutical form
-
Route of administration
INTRAVENOUS INFUSION
Max daily dose
2400 mg milligram(s)
Max total dose
3200 mg milligram(s)
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
L04A — IMMUNOSUPPRESSIVE AGENTS
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Gemcitabine

SCP1686259 · ATC

Active substance
Gemcitabine
Route of administration
INTRAVENOUS INFUSION
Max daily dose
1000 mg/m2 milligram(s)/sq. meter
Max total dose
1000 mg/m2 milligram(s)/sq. meter
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L01BC05 — GEMCITABINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

R06A · Product

Pharmaceutical form
-
Route of administration
ORAL AND IV
Max daily dose
25 mg milligram(s)
Max total dose
25 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
R06A — ANTIHISTAMINES FOR SYSTEMIC USE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Mesna

SCP4962220 · ATC

Active substance
Mesna
Substance synonyms
SODIUM 2-MERCAPTOETHANESULPHONATE
Route of administration
INTRAVENOUS INJECTION
Max daily dose
540 mg/m2 milligram(s)/sq. meter
Max total dose
1620 mg/m2 milligram(s)/sq. meter
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
V03AF01 — MESNA
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Anhydrous Cyclophosphamide

SCP1728208 · ATC

Active substance
Anhydrous Cyclophosphamide
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
750 mg/m2 milligram(s)/sq. meter
Max total dose
1500 mg/m2 milligram(s)/sq. 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

Carboplatin

SCP28192792 · ATC

Active substance
Carboplatin
Route of administration
INTRAVENOUS INFUSION
Max daily dose
800 mg milligram(s)
Max total dose
800 mg milligram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
L01XA02 — CARBOPLATIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Betamethasone Sodium Phosphate Ph. Eur

SCP1977137 · ATC

Active substance
Betamethasone Sodium Phosphate Ph. Eur
Substance synonyms
DEXAMETHASONE SODIUM PHOSPHATE PH. EUR
Route of administration
ORAL AND IV
Max daily dose
40 mg milligram(s)
Max total dose
480 mg milligram(s)
Max treatment duration
12 Day(s)
Authorisation status
Authorised
ATC code
H02AB02 — DEXAMETHASONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Methylprednisolone

SCP26856619 · ATC

Active substance
Methylprednisolone
Substance synonyms
6-METHYLPREDNISOLONE
Route of administration
INTRAVENOUS USE
Max daily dose
3000 mg milligram(s)
Max total dose
36000 mg milligram(s)
Max treatment duration
12 Day(s)
Authorisation status
Authorised
ATC code
H02AB04 — METHYLPREDNISOLONE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Ifosfamide

SCP5478032 · ATC

Active substance
Ifosfamide
Route of administration
INTRAVENIOUS INFUSION
Max daily dose
5000 mg/m2 milligram(s)/sq. meter
Max total dose
15000 mg/m2 milligram(s)/sq. meter
Max treatment duration
3 Day(s)
Authorisation status
Authorised
ATC code
L01AA06 — IFOSFAMIDE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Rituximab

SCP24437829 · ATC

Active substance
Rituximab
Substance synonyms
CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
Route of administration
INTRAVENOUS USE
Max daily dose
375 mg/m2 milligram(s)/sq. meter
Max total dose
750 mg/m2 milligram(s)/sq. meter
Max treatment duration
2 Day(s)
Authorisation status
Authorised
ATC code
L01XC02 — RITUXIMAB
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Fludarabine

SCP9025814 · ATC

Active substance
Fludarabine
Route of administration
INTRAVENOUS INFUSION
Max daily dose
30 mg/m2 milligram(s)/sq. meter
Max total dose
90 mg/m2 milligram(s)/sq. 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

Kite Pharma Inc.

13 Total trials 3 Recruiting 10 Ended
Commercial
Sponsor organisation
Kite Pharma Inc.
Address
2225 Colorado Avenue
City
Santa Monica
Postcode
90404-3505
Country
United States

Scientific contact point

Organisation
Kite Pharma Inc.
Contact name
EU Clinical Trials Support

Public contact point

Organisation
Kite Pharma Inc.
Contact name
EU Clinical Trials Support

Third parties 10

OrganisationCity, countryDuties
Neogenomics Laboratories Inc.
ORG-100041804
 Aliso Viejo, United States Other, Laboratory analysis
Labcorp Central Laboratories Services LP
ORG-100032236
 Indianapolis, United States Other, Laboratory analysis
Bioagilytix Labs LLC
ORG-100013030
 Durham, United States Other, Laboratory analysis
PPD Global Limited
ORG-100007533
 Cambridge, United Kingdom Other, Code 5
Medidata Solutions Inc.
ORG-100016256
 New York, United States Other, E-data capture
Cellcarta Fremont LLC
ORG-100042774
 Fremont, United States Other, Laboratory analysis
Bioclinica Inc.
ORG-100033079
 Princeton, United States Other, Data management
Nanostring Technologies Inc.
ORG-100044077
 Seattle, United States Other, Laboratory analysis
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland Other, Laboratory analysis
Eurofins Viracor Biopharma Services Inc.
ORG-100041736
 Lenexa, United States Other, Laboratory analysis

Locations

7 EU/EEA countries · 14 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ended 2 1
France Ended 4 2
Germany Ended 2 3
Italy Ended 4 3
Netherlands Ended 2 1
Spain Ended 3 3
Sweden Ended 1 1
Rest of world
United States, United Kingdom, Canada
 — 15 —

Investigational sites

Austria

1 site · Ended
Medical University Of Vienna
Department of Medicine I, Division of Hematology, Hemostaseology, Waehringer Guertel 18-20, Alsergrund, Vienna

France

2 sites · Ended
Institut Universitaire Du Cancer Toulouse-Oncopole
Service d'Hematologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Pitie Salpetriere Hospital
Service d'Hematologie Clinique, 47 Boulevard De L Hopital, 75651, Paris Cedex 13

Germany

3 sites · Ended
Heidelberg University Hospital AöR
Klinik für Hämatologie, Onkologie, Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitatsklinikum Ulm AöR
Klinik für Innere Medizin III – Hämatologie, Onkologie, Rheumatologie, Infektionskrankheiten, Albert-Einstein-Allee 23, Eselsberg, Ulm
University Hospital Cologne AöR
Centrum für Integrierte Onkologie (CIO), Studienzentrum der Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne

Italy

3 sites · Ended
Azienda Ospedaliera Ospedale Niguarda Ca Granda
S.C. Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
S Orsola Policlinic Hospital
UOC di Ematologia Dipartimento Malattie Oncologiche ed Ematologiche, Via Giuseppe Massarenti 9, 40138, Bologna
Hospital Santa Maria Della Misericordia
Struttura Complessa di Ematologia con Trapianto e Sezione di Ematologia ed Immunologia Clinica, Piazzale Giorgio Menghini 1, 06129, Perugia

Netherlands

1 site · Ended
Stichting Radboud University Medical Center
Department of Hematology, 476, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen

Spain

3 sites · Ended
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
University Hospital Virgen Del Rocio S.L.
Hematology and Hemotherapy, Avenida De Manuel Siurot S/n, 41013, Sevilla

Sweden

1 site · Ended
Region Skane - Skanes Universitetssjukhus
VO Hematologi, Onkologi & Strålningsfysik, Entregatan 7, Lunds Allhelgonafors, Lund

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2023-11-17
France 2023-07-06
Germany 2023-08-30
Italy 2023-06-23 2024-11-27 2023-07-03 2024-06-13
Netherlands 2023-04-14 2024-10-01 2023-06-09 2024-06-13
Spain 2023-04-27 2024-10-22 2023-06-06 2024-06-13

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

TitleSubmission dateStatusType
FINAL SUMMARY OF CLINICAL STUDY RESULTS
SUM-111439
 2025-12-16T16:31:59 Submitted Summary of Results

Layperson summary Annex V

TitleSubmission dateStatusType
KT-US-568-0138-C Plain Language Summary 2025-12-16T18:55:20 Submitted Laypersons Summary of Results

Documents 47 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Laypersons summary of results (for publication) KT-US-568-0138-C Plain Language Summary 1
Laypersons summary of results (for publication) KT-US-568-0138-C Plain Language Summary_NL 1
Laypersons summary of results (for publication) KT-US-568-0138-C Plain Language Summary-ES 1
Laypersons summary of results (for publication) KT-US-568-0138-C Plain Language Summary-IT 1
Protocol (for publication) D4_ Patient facing documents_AT_Health questionnaire 1.1
Protocol (for publication) D4_ Patient facing documents_DE_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_DE_Health questionnaire 1
Protocol (for publication) D4_ Patient facing documents_ENG_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_ES_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_ES_Health questionnaire 1
Protocol (for publication) D4_ Patient facing documents_FR_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_FR_Health questionnaire 1.2
Protocol (for publication) D4_ Patient facing documents_IT_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_IT_Health questionnaire 1.1
Protocol (for publication) D4_ Patient facing documents_NL_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_NL_Health questionnaire 1.1
Protocol (for publication) D4_ Patient facing documents_SE_EORTC QLQ questionnaire 3
Protocol (for publication) D4_ Patient facing documents_SE_Health questionnaire 1.1
Protocol (for publication) D5_ Master protocol_2022-501261-46-00_Redacted 3
Protocol (for publication) D5_ Master protocol_2022-501261-46-00_Redacted_TC 1.1
Protocol (for publication) D5_Protocol Administrative Master 2022-501261-46-00_redacted 1
Protocol (for publication) D5_Protocol Administrative Substudy 2022-501261-46-00_redacted 1
Protocol (for publication) D5_Protocol Substudy 2022-501261-46-00_redacted 3
Protocol (for publication) D5_Protocol Substudy 2022-501261-46-00_Redacted_TC 1.1
Summary of results (for publication) 568-0138-C CTIS Results Final 1
Synopsis of the protocol (for publication) D1_ Protocol synopsis Master_AT_2022-501261-46-00 3.0
Synopsis of the protocol (for publication) D1_ Protocol synopsis master_DE_2022-501261-46-00 3.0
Synopsis of the protocol (for publication) D1_ Protocol synopsis Master_DE_2022-501261-46-00_TC 3
Synopsis of the protocol (for publication) D1_ Protocol synopsis master_ES_2022-501261-46-00 3.0
Synopsis of the protocol (for publication) D1_ Protocol synopsis Master_ES_2022-501261-46-00_TC 3
Synopsis of the protocol (for publication) D1_ Protocol synopsis master_FR_2022-501261-46-00 3.0
Synopsis of the protocol (for publication) D1_ Protocol synopsis master_FR_2022-501261-46-00_TC 3
Synopsis of the protocol (for publication) D1_ Protocol synopsis master_IT_2022-501261-46-00 3.0
Synopsis of the protocol (for publication) D1_ Protocol synopsis master_IT_2022-501261-46-00_TC 3
Synopsis of the protocol (for publication) D1_ Protocol synopsis Master_NL_2022-501261-46-00 3.0
Synopsis of the protocol (for publication) D1_ Protocol synopsis Master_NL_2022-501261-46-00_TC 3
Synopsis of the protocol (for publication) D1_ Protocol synopsis substudy_AT_2022-501261-46-00 3.0
Synopsis of the protocol (for publication) D1_ Protocol synopsis substudy_DE_2022-501261-46-00_Redacted 3.0
Synopsis of the protocol (for publication) D1_ Protocol synopsis substudy_DE_2022-501261-46-00_TC 3
Synopsis of the protocol (for publication) D1_ Protocol synopsis substudy_ES_2022-501261-46-00 3
Synopsis of the protocol (for publication) D1_ Protocol synopsis Substudy_ES_2022-501261-46-00_TC 3
Synopsis of the protocol (for publication) D1_ Protocol synopsis substudy_FR_2022-501261-46-00 3.0
Synopsis of the protocol (for publication) D1_ Protocol synopsis substudy_FR_2022-501261-46-00_TC 3
Synopsis of the protocol (for publication) D1_ Protocol synopsis substudy_IT_2022-501261-46-00 3
Synopsis of the protocol (for publication) D1_ Protocol synopsis substudy_IT_2022-501261-46-00_TC 3
Synopsis of the protocol (for publication) D1_ Protocol synopsis substudy_NL_2022-501261-46-00 3.0
Synopsis of the protocol (for publication) D1_ Protocol synopsis substudy_NL_2022-501261-46-00_TC 3

Application history

8 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-10-07 Spain Acceptable
2023-02-13
 2023-02-13
2 SUBSTANTIAL MODIFICATION SM-1 2023-03-07 Acceptable 2023-04-19
3 SUBSTANTIAL MODIFICATION SM-2 2023-03-13 Acceptable 2023-04-25
4 SUBSTANTIAL MODIFICATION SM-4 2023-03-24 Acceptable 2023-05-09
5 SUBSTANTIAL MODIFICATION SM-5 2023-03-28 Spain Acceptable 2023-05-10
6 SUBSTANTIAL MODIFICATION SM-7 2023-10-06 Spain Acceptable
2023-12-11
 2023-12-11
7 SUBSTANTIAL MODIFICATION SM-8 2024-03-20 Spain Acceptable
2024-05-16
 2024-05-16
8 SUBSTANTIAL MODIFICATION SM-9 2024-11-15 Spain Acceptable
2025-03-10
 2025-03-10