Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
384
Countries
3
Sites
17
melanoma, cutaneous malignant
To evaluate the efficacy of IMA203 compared with control (investigator’s choice)
Key facts
- Sponsor
- Immatics US Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 May 2025 → ongoing
- Decision date (initial)
- 2026-04-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Immatics US Inc · Immatics Biotechnologies GmbH
External identifiers
- EU CT number
- 2024-517062-42-00
- ClinicalTrials.gov
- NCT06743126
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To evaluate the efficacy of IMA203 compared with control (investigator’s choice)
Conditions and MedDRA coding
melanoma, cutaneous malignant
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088049 | Cutaneous melanoma | 100000004848 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Phase 3: Randomized trial (IMA203-301) Comparison of IMA203 versus investigator’s choice of treatment in patients with previously treated, unresectable or metastatic cutaneous melanoma. The trial seeks to further evaluate the safety and efficacy of IMA203 administered at the recommended Phase 2 dose (RP2D).
|
Randomised Controlled | None | [{"id":167676,"code":1,"name":"Subject"}] | Experimental arm: Lymphodepletion (LD) with cyclophosphamide (CY) and fludarabine (FLU) will occur in the days before the IMA203 product infusion to improve the duration of time that IMA203 product stays in the body. After the IMA203 product infusion, a low dose of interleukin (IL)-2 will be given. Control arm (active comparator): Investigator’s choice of treatment as available and approved by the respective Competent Authority (nivolumab plus relatlimab [Opdualag®], lifileucel, nivolumab, pembrolizumab, ipilimumab, or chemotherapy [e.g., dacarbazine, temozolomide, paclitaxel, albbound paclitaxel, or paclitaxel plus carboplatin]) as determined by the site investigator in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC). |
Regulatory references
- Scientific advice from competent authorities
- Paul-Ehrlich-Institut, Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Patients ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
- Confirmed HLA status
- Adequate renal, hepatic and pulmonary function, acceptable coagulation status, adequate organ and marrow function
- Measurable disease according to RECIST 1.1
- Pathologically confirmed and documented cutaneous melanoma, CM patients with unresectable or metastatic (= advanced) disease who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor
- Patients with BRAF mutation should have been treated with one prior line of BRAF-directed therapy unless deemed not clinically indicated at Investigator’s discretion due to concurrent medical condition, prior toxicity, or if declined by the patient
- The patient must have recovered from any side effects of prior therapy to grade 1 or lower prior to randomization, and prior to LD and subsequent treat-ment
Exclusion criteria 8
- Primary mucosal or uveal melanoma
- History of other malignancies within the last 3 years
- Patients with prior allogeneic stem-cell transplantation or solid-organ transplantation
- The patient is pregnant or is breastfeeding.
- History of hypersensitivity to treatment in the IMA203 arm or rescue medications or presence of any contraindications and other limitations for planned treatment with investigator’s choice
- Any condition contraindicating leukapheresis
- The patient has concurrent severe and/or uncontrolled medical disease. Any other condition that would, in the investigator’s judgement, contraindicate the patient’s participation in the clinical trial because of safety concerns or com-pliance with clinical trial procedures
- Patients with active brain metastases or leptomeningeal metastases at VA/VB
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Progression-free survival (PFS), centrally assessed by a Blinded Independent Central Review (BICR) using RECIST 1.1
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD7629213 · Product
- Active substance
- Autologous T-Cells Transduced with the Lentiviral LV-R11KEA Encoding T-Cell Receptor Targeting Patient-Specific Tumor-Associated Antigens
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 10000000000 DF dosage form
- Max total dose
- 10000000000 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- IMMATICS US INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 11
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 200 mg/m2 milligram(s)/sq. meter
- Max total dose
- 8000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10889MIG · Substance
- Active substance
- Temozolomide
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL
- Max daily dose
- 200 mg/m2 milligram(s)/sq. meter
- Max total dose
- 8000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB127678 · Substance
- Active substance
- Paclitaxel Albumin-Bound
- Pharmaceutical form
- POWDER FOR DISPERSION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB122750 · Substance
- Active substance
- Nivolumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 9600 mg milligram(s)
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB122750 · Substance
- Active substance
- Nivolumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 3840 mg milligram(s)
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB167136 · Substance
- Active substance
- Pembrolizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 2000 mg milligram(s)
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06882MIG · Substance
- Active substance
- Dacarbazine
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION OR INFUSION
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 250 mg/m2 milligram(s)/sq. meter
- Max total dose
- 12500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB29397 · Substance
- Active substance
- Ipilimumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 3 mg/kg milligram(s)/kilogram
- Max total dose
- 12 mg/kg milligram(s)/kilogram
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB09583MIG · Substance
- Active substance
- Paclitaxel
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 225 mg/m2 milligram(s)/square meter
- Max total dose
- 2250 mg/m2 milligram(s)/square meter
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 900 mg milligram(s)
- Max total dose
- 9000 mg milligram(s)
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Opdualag 240 mg/80 mg concentrate for solution for infusion
PRD9942315 · Product
- Active substance
- Nivolumab
- Substance synonyms
- BMS936558, ABP 206
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 480 mg milligram(s)
- Max total dose
- 3840 mg milligram(s)
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FY02 — -
- Marketing authorisation
- EU/1/22/1679/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Immatics US Inc.
- Sponsor organisation
- Immatics US Inc.
- Address
- 13203 Murphy Road
- City
- Stafford
- Postcode
- 77477-4303
- Country
- United States
Scientific contact point
- Organisation
- Immatics US Inc.
- Contact name
- Clinical Development
Public contact point
- Organisation
- Immatics US Inc.
- Contact name
- Clinical Development
Third parties 15
| Organisation | City, country | Duties |
|---|---|---|
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | Other, E-data capture |
| Metronomia Clinical Research GmbH ORG-100012892
|
Munich, Germany | Code 10, Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Other |
| Discovery Life Sciences Biomarker Services GmbH ORG-100042520
|
Kassel, Germany | Laboratory analysis |
| Cogitars GmbH ORG-100044720
|
Heidelberg, Germany | Code 10 |
| CCR Creative Clinical Research GmbH Privates Institut fuer Kreative Klinische Forschung ORG-100052836
|
Berlin, Germany | Code 13 |
| Imaging Endpoints II LLC ORG-100045399
|
Scottsdale, United States | Other |
| Cerba Research ORG-100042694
|
Gent, Belgium | Other, Laboratory analysis |
| ProtaGene CGT GmbH ORG-100041450
|
Heidelberg, Germany | Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Morrisville, United States | Laboratory analysis |
| Genewiz Germany GmbH ORG-100049496
|
Leipzig, Germany | Laboratory analysis |
| spm²-safety projects & more GmbH ORG-100013935
|
Hirschberg An Der Bergstrasse, Germany | Code 8 |
| MicroCoat Biotechnologie GmbH ORG-100031937
|
Bernried Am Starnberger See, Germany | Laboratory analysis |
| Angle Europe Limited ORG-100051451
|
Guildford, United Kingdom | Laboratory analysis |
| Winicker-Norimed GmbH Medizinische Forschung ORG-100035700
|
Nuremberg, Germany | Code 11 |
Locations
3 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 12 | 3 |
| Germany | Ongoing, recruiting | 84 | 11 |
| Netherlands | Authorised, recruitment pending | 12 | 3 |
| Rest of world
United States
|
— | 276 | — |
Investigational sites
Institut Gustave Roussy
Dermatology, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Lille
Dermatology, Rue Michel Polonowski, 59000, Lille
Assistance Publique Hopitaux De Paris
Hôpital Saint Louis Dermatology, 1 Avenue Claude Vellefaux, 75010, Paris
Technische Universitaet Dresden
Early Clinical Trial Unit (NCT/UCC ECTU), Fetscherstrasse 74, Johannstadt-Nord, Dresden
University Medical Center Hamburg-Eppendorf
Klinik und Poliklinik für Dermatologie und Venerologie, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Essen AöR
Department for Dermatology, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Erlangen AöR
Department of Dermatology, Ulmenweg 18, Innenstadt, Erlangen
Universitaetsklinikum Bonn AöR
Medizinische Klinik und Poliklinik III, Venusberg-Campus 1, Venusberg, Bonn
Universitaetsklinikum Heidelberg AöR
DermatoOnkologie der Hautklinik im Nationalen Centrum für Tumorerkrankungen (NCT), Im Neuenheimer Feld 460, Neuenheim, Heidelberg
Universitaet Leipzig
Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie, Philipp-Rosenthal-Strasse 23, Zentrum-Suedost, Leipzig
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
III. Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Goethe University Frankfurt
Abteilung für Dermatologie, Venerologie und Allergologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Charite Universitaetsmedizin Berlin KöR
Klinik für Hämatologie und Onkologie, Comprehensive Cancer Center (CCC), Hindenburgdamm 30, Lichterfelde, Berlin
University Hospital Cologne AöR
Klinik und Poliklinik für Dermatologie und Venerologie, Kerpener Strasse 62, Lindenthal, Cologne
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Centrum voor Celtherapie, Plesmanlaan 121, 1066 CX, Amsterdam
Universitair Medisch Centrum Groningen
Medical Oncology, Hanzeplein 1, 9713 GZ, Groningen
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Medical Oncology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
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 |
|---|---|---|---|---|---|
| Germany | 2025-05-02 | 2025-05-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 62 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-517062-42-00_Redacted | 3 |
| Protocol (for publication) | D4_EORTC QLQ-C30_DE_EN_Redacted | 3 |
| Protocol (for publication) | D4_EQ-5D-5L_DE_EN_Redacted | 1 |
| Protocol (for publication) | D4_Patient Card_DE_Redacted | 2 |
| Protocol (for publication) | D4_Patient questionnaire_DE_EN_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_document additionnel_FR_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NL_Redacted | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Redacted | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_graphical overview_DE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_graphical overview_EN_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_graphical overview_EN_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_graphical overview_EN_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_graphical overview_FR_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_graphical overview_NL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IMA203-301 trial website_DE_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IMA203-301 trial website_EN_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IMA203-301 trial website_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_IMA203-301 trial website_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_social media posts_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_social media posts_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults ICF1_DE_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults ICF1_EN_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults ICF1_EN_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults ICF1_FR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults ICF1_NL_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults ICF2_DE_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults ICF2_EN_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults ICF2_EN_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults ICF2_FR_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults ICF2_NL_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults legal guardian_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults legal guardian_EN_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults optional biosample_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults optional biosample_EN_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults pregnant partner_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults pregnant partner_EN_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults pregnant partner_EN_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults pregnant partner_FR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults pregnant partner_NL_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire_ICF_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire_ICF_EN_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire_ICF_EN_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire_ICF_FR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_pregnancy follow-up_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_pregnancy follow-up_EN_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_Privacy Notice_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_Privacy Notice_EN_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material description_IMA203_301_Pathway_DE_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material description_IMA203_301_Pathway_EN_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material description_IMA203_301_Pathway_EN_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material description_IMA203_301_Pathway_FR_Redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Alb-bound Paclitaxel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Carboplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Dacarbazine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ipilimumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Nivolumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Opdualag | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Paclitaxel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Pembrolizumab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Temozolomide | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol layperson synopsis_DE 2024-517062-42-00_Redacted | 2 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-15 | Germany | Acceptable 2025-04-15
|
2025-04-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-18 | Germany | Acceptable 2025-08-26
|
2025-08-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-14 | Germany | Acceptable 2025-12-18
|
2025-12-18 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2026-01-21 | Acceptable 2025-12-18
|
2026-04-20 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2026-01-21 | Acceptable 2025-12-18
|
2026-04-13 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-23 | Germany | Acceptable | 2026-03-04 |