Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
504
Countries
7
Sites
27
Solid and Hematological Malignancies
Evaluate the incidence and severity of late-onset targeted AEs/serious AEs (SAEs) suspected to be possibly related to gene-modified cells, including neurological disorders, autoimmune disorders, hematological disorders, serious infections, and new malignancies. Evaluate the growth, development, and sexual maturity of …
Key facts
- Sponsor
- Kite Pharma Inc.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Nov 2022 → ongoing
- Decision date (initial)
- 2024-07-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Kite Pharma Inc.
External identifiers
- EU CT number
- 2023-507041-28-00
- EudraCT number
- 2020-005843-21
- ClinicalTrials.gov
- NCT05041309
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
Evaluate the incidence and severity of late-onset targeted AEs/serious AEs (SAEs) suspected to be possibly related to gene-modified cells, including neurological disorders, autoimmune disorders, hematological disorders, serious infections, and new malignancies.
Evaluate the growth, development, and sexual maturity of pediatric and adolescent subjects treated with gene-modified cells
Secondary objectives 5
- Determine the time to next treatment after administration of gene-modified cells in the completed parent study
- Determine survival status
- Determine cause of death
- Determine the status of the primary malignant disease
- Evaluate the incidence of overall replication-competent retrovirus (RCR)/ replication-competent lentivirus (RCL)
Conditions and MedDRA coding
Solid and Hematological Malignancies
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2020-005843-21 | Long-term Follow-up Study for Participants of Kite Sponsored Interventional Studies Treated With Gene-Modified Cells, Studio di follow up a lungo termine per i partecipanti a studi interventistici sponsorizzati da Kite e trattati con cellule geneticamente modificate, Estudio de seguimiento a largo plazo para participantes de estudios intervencionistas financiados por Kite tratados con células genomodificadas |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- The subject must have received an infusion of gene-modified cells in a completed Kite-sponsored parent study, has not withdrawn full consent or discontinued the parent study, and must have completed the minimum duration of follow-up assessments in the parent study, as applicable.
- The subject must understand and voluntarily sign an Informed Consent Form (ICF) or an Informed Assent Form prior to any study-related assessments or procedures being conducted.
- In the investigator’s judgment, the subject must be willing and able to complete the protocol-required follow-up schedule and comply with the study requirements for participation.
Exclusion criteria 1
- There are no specific exclusion criteria for this study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 7
- Assess the occurrence of the following late-onset targeted AEs/SAEs suspected to be possibly related to gene-modified cells:
- Neurologic disorders: type, date of onset, severity, treatment, and date of resolution
- Autoimmune disorders: type, date of onset, severity, treatment, and date of resolution
- Hematologic disorders: type, date of onset, severity, treatment, and date of resolution
- Serious infections (eg, viral, bacterial, or fungal): type, organism, and timing of infection
- New malignancies: time to development of the New malignancy, type, location, staging and molecular mechanism (including testing for presence of the chimeric antigen receptor transgene and RCR/RCL
- Height, weight, and sexual maturation of pediatric and adolescent subjects
Secondary endpoints 5
- Subsequent anti-cancer therapies
- Survival status
- Cause of death
- Overall rates of RCR/RCL
- Status of the primary malignant disease
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
PRD11252785 · Product
- Active substance
- KITE-363
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 DF dosage form
- Max total dose
- 0 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- KITE PHARMA INC.
- Paediatric formulation
- No
- Orphan designation
- No
Tecartus 0.4 - 2 x 10e8 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
- L01XL06 — -
- 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
- Yes
- Modification description
- Additional Description : Tecartus (brexucabtagene autoleucel) is a genetically modified autologous cell-based product containing T cells transduced ex vivo using a retroviral vector expressing an anti CD19 chimeric antigen receptor (CAR) comprising a murine anti CD19 single chain variable fragment (scFv) linked to CD28 co-stimulatory domain and CD3-zeta signalling domain.
YESCARTA 0.4 – 2 x 10e8 cells dispersion for infusion
PRD6563420 · Product
- Active substance
- Axicabtagene Ciloleucel
- 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
- L01XX70 — -
- Marketing authorisation
- EU/1/18/1299/001
- MA holder
- KITE PHARMA EU B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/14/1393
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- A genetically modified autologous cell-based product containing T cells transduced ex vivo using a retroviral vector expressing an anti-CD19 chimeric antigen receptor (CAR) comprising a murine anti-CD19 single chain variable fragment (ScFv) linked to CD28 co-stimulatory domain and CD3-zeta signalling domain.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kite Pharma Inc.
- Sponsor organisation
- Kite Pharma Inc.
- Address
- 2400 Broadway
- City
- Santa Monica
- Postcode
- 90404-3030
- Country
- United States
Scientific contact point
- Organisation
- Kite Pharma Inc.
- Contact name
- EU CT Support
Public contact point
- Organisation
- Kite Pharma Inc.
- Contact name
- EU CT Support
Third parties 6
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
| Molecularmd Corp. ORG-100047559
|
Portland, United States | Laboratory analysis |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 12, Code 13, Code 5 |
| Neogenomics Laboratories Inc. ORG-100041804
|
Aliso Viejo, United States | Laboratory analysis |
Locations
7 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 1 | 1 |
| Belgium | Ongoing, recruiting | 1 | 1 |
| France | Ongoing, recruiting | 31 | 7 |
| Germany | Ongoing, recruiting | 16 | 6 |
| Italy | Ongoing, recruiting | 2 | 2 |
| Netherlands | Ongoing, recruiting | 30 | 5 |
| Spain | Ongoing, recruiting | 15 | 5 |
| Rest of world
Japan, United States, United Kingdom, Canada, Israel, Australia, Switzerland
|
— | 408 | — |
Investigational sites
Medizinische Universitaet Innsbruck
Internal Medicine V – Hematology & Oncology, Anichstrasse 35, 6020, Innsbruck
Centre Hospitalier Universitaire De Rennes
Clinical Hematology Department, 2 Rue Henri Le Guilloux, 35000, Rennes
Hopital Saint Louis
Hematology Adolescent and Young Adult Unit, 1 Avenue Claude Vellefaux, 75010, Paris
University Hospital Of Montpellier
Clinical Hematology Department, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Hospices Civils De Lyon
Clinical Hematology Department, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Universitaire De Lille
Transplant and blood disorders department, Rue Michel Polonowski, 59000, Lille
Hopital Saint Louis
Hemato-Oncology Department, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Bordeaux
Hematology and Cellular Therapy Department, Avenue De Magellan, 33600, Pessac
Universitaetsklinikum Heidelberg AöR
Innere Medizin V, Klinik fur Haematologie, Onkologie, Rheumatologie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
University Medical Center Hamburg-Eppendorf
Paediatric Haematology and Oncology, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Wuerzburg AöR
Hematology Department, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
lll. Medizinische Klinik und Poliklinik: Haematologie und Medizinische Onkologie, Langenbeckstrasse 1, Oberstadt, Mainz
Klinikum der Universitaet Muenchen AöR
Laboratory for translational cancer Immunology, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Trial Management and Early Clinical Trial Unit, Fetscherstrasse 74, Johannstadt-Nord, Dresden
ASST Grande Ospedale Metropolitano Niguarda
S.C. Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Ospedale Pediatrico Bambino Gesu
Clinical Oncohaematology and Cell Therapy Studies, Piazza Di Sant'onofrio 4, 00165, Rome
Stichting Radboud University Medical Center
Department of Hematology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hematology Department, 's-Gravendijkwal 230, 3015 CE, Rotterdam
Universitair Medisch Centrum Groningen
Hematology Department, Hanzeplein 1, 9713 GZ, Groningen
Universitair Medisch Centrum Utrecht
Department of Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Academisch Medisch Centrum
Clinical Hematology Department, Meibergdreef 9, 1105 AZ, Amsterdam
Hospital Clinic De Barcelona
Hematology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Salamanca
Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitari Vall D Hebron
Hematology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Institut Catala D'oncologia
Hematology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Sant Joan De Deu Barcelona
Pediatric Hemato-Oncology, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
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 |
|---|---|---|---|---|---|
| Austria | 2024-08-14 | 2024-08-28 | |||
| Belgium | 2024-10-15 | 2024-10-28 | |||
| France | 2023-03-10 | 2023-04-24 | |||
| Germany | 2022-12-21 | 2023-02-16 | |||
| Italy | 2024-11-21 | 2024-11-27 | |||
| Netherlands | 2022-11-28 | 2022-12-07 | |||
| Spain | 2024-06-17 | 2024-08-06 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-IT-0001
- Member state
- Italy
- Publication date
- 2025-07-28
- Type
- 1
- Reason
- 6
- Reverted date
- 2025-07-28
- Immediate action required
- Yes
- Notes
- Reverted (2025-07-28)
- Justification
- Dear Applicant,
Considering the expiration of the three-year mandate of the members of the National Ethics Committee (CEN) for clinical trials relating to advanced therapies (“ATMP”) and of the National Ethics Committee (CEN) for clinical trials in the pediatric field, appointed by Decree of the Minister of Health - 2 March 2022;
Considering the fact that, due to the expiration of the mandate of the members of the aforementioned National Ethics Committee (CEN), for the procedure in subject the assessment of the aspects relating to Part II of the evaluation report pursuant to art. 7 of the aforementioned Regulation (EU) No. 536/2014 has not been carried out, and as a result there is no conclusion of Part II for the EU CT 2023-507041-28-00 procedure (AIFA authorization provision n° 0053101-30/04/2025-AIFA-AIFA_USC-P);
In compliance with CHAPTER XIII (SUPERVISION BY MEMBER STATES, UNION INSPECTIONS AND CONTROLS) of Regulation 536/2014 with specific reference to Article 77 (Corrective measures to be taken by Member States):
1. Where a Member State concerned has justified grounds for considering that the requirements set out in this Regulation are no longer met, it may take the following measures on its territory:
(a) revoke the authorisation of a clinical trial;
(b) suspend a clinical trial;
(c) require the sponsor to modify any aspect of the clinical trial.
A corrective measure is applied suspending the trial. This corrective measure is only applicable to Italy
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 77 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-507041-28-00_redact | 3.0 |
| Protocol (for publication) | D4_Patient Facing Document_Survival FUP Form | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Patient Card LTFU | 0.1 |
| Protocol (for publication) | D4_Patient facing documents_Patient Card LTFU | 0.1 |
| Protocol (for publication) | D4_Patient facing documents_Patient Card LTFU | 0.1 |
| Protocol (for publication) | D4_Patient facing documents_Patient Card LTFU | 0.1 |
| Protocol (for publication) | D4_Patient facing documents_Patient Card LTFU | 0.1 |
| Protocol (for publication) | D4_Patient facing documents_Site Questionnaire HCG GP | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Site Questionnaire HCG GP | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Site Questionnaire HCP GP | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Site Questionnaire HCP GP | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Site Questionnaire HCP GP | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Site to Subject Form | 1.1 |
| Protocol (for publication) | D4_Patient facing documents_Site to Subject Questionnaire | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Site to Subject Questionnaire | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Site to Subject Questionnaire | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Site to Subject Questionnaire | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Survival FUP | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Survival FUP Form | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Survival FUP Form | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Survival FUP Form | 1.0 |
| Recruitment arrangements (for publication) | K1_AT_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_BE_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_DE_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_ES_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_FR_Recruitment Procedure_Bilingual | 1.0 |
| Recruitment arrangements (for publication) | K1_IT_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_NL_Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K2_DE_Recruitment Material_GP letter_German_redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_DE_Recruitment Material_GP letter_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Adults_German_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Pregnant Participant_German | 1.2 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_Pregnant Partner_German | 1.2 |
| Subject information and informed consent form (for publication) | L1_AT_SIS-ICF_site contact data protection list_German_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_Dutch_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_French_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Main_Redacted | 3.2 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Participant | 1.2 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Participant_Dutch | 1.2 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Participant_French | 1.2 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Partner | 1.2 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Partner_Dutch | 1.2 |
| Subject information and informed consent form (for publication) | L1_BE_SIS-ICF_Pregnant Partner_French | 1.2 |
| Subject information and informed consent form (for publication) | L1_BE_Sponsor statement on Main ICF_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Future Research and Genetic Testing ICF_German_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Future Research and Genetic Testing ICF_redacted | 3.4 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Main ICF_German_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Main ICF_redacted | 3.4 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Optional Biopsies ICF_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Optional Procedures ICF_German_redacted | 3.2 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnant Participant ICF | 1.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnant Participant ICF_German | 2.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnant Partner ICF | 1.1 |
| Subject information and informed consent form (for publication) | L1_DE_SIS-ICF_Pregnant Partner ICF_German | 2.1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Assent 12-17_Spanish | 3.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Assent 6-11_Spanish | 2.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Main_Spanish_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Parent_Spanish_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnant Participant_Spanish | 1.1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Pregnant Partner_Spanish | 1.1 |
| Subject information and informed consent form (for publication) | L1_ES_SIS-ICF_Scout_Spanish | 1.0 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Main_French_redacted | 4.2 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Pregnant Partner_French | 1.2 |
| Subject information and informed consent form (for publication) | L1_FR_SIS-ICF_Pregnant Patient_French_redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_LTFU_Italian_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Pregnant Participant_Italian | 1.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_Pregnant Partner_Italian | 1.0 |
| Subject information and informed consent form (for publication) | L1_IT_SIS-ICF_privacy and data protection_Italian | 5.0 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Main_Dutch_redacted | 5.2 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Pregnant Participant ICF_Dutch | 1.3 |
| Subject information and informed consent form (for publication) | L1_NL_SIS-ICF_Pregnant Partner ICF_Dutch_redacted | 1.3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_2023-507041-28-00 | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE_2023-507041-28-00_redact | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-507041-28-00_redact | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2023-507041-28-00_redact | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2023-507041-28-00_redact | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL_2023-507041-28-00_redact | 3 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-16 | Spain | Acceptable 2023-11-17
|
2023-11-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-20 | Spain | Acceptable 2024-03-11
|
2024-03-11 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-04-05 | Acceptable 2024-03-11
|
2024-07-01 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-04-19 | Acceptable 2024-03-11
|
2024-06-20 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2024-05-02 | Acceptable 2024-03-11
|
2024-07-23 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-08-09 | Acceptable | 2024-08-26 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-09 | Acceptable | 2024-09-10 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-26 | Spain | Acceptable 2024-12-02
|
2024-12-03 |
| 9 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-01-22 | Spain | Acceptable 2025-04-28
|
2025-04-28 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-11 | Acceptable 2025-04-28
|
2025-08-11 | |
| 11 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-13 | Acceptable | 2025-09-23 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-11-03 | Spain | Acceptable 2026-02-26
|
2026-02-26 |