Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
7
Neuroblastoma
To evaluate long-term safety after treatment with GD2IL18CART
Key facts
- Sponsor
- Universitaet Muenster
- 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
- 6 Oct 2025 → ongoing
- Decision date (initial)
- 2025-09-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Deutsche Krebshilfe (German Cancer Aid)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To evaluate long-term safety after treatment with GD2IL18CART
Secondary objectives 2
- To further assess safety concerning growth and development in pediatric patients
- To evaluate long-term treatment efficacy as measured by status of disease progression and survival status over time and to evaluate persistence of the transgene
Conditions and MedDRA coding
Neuroblastoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10031291 | Osteosarcoma | 100000004864 |
| 20.0 | PT | 10015560 | Ewing's sarcoma | 100000004864 |
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 20.0 | PT | 10029260 | Neuroblastoma | 100000004864 |
Regulatory references
- Scientific advice from competent authorities
- Paul-Ehrlich-Institut
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-501725-21-00 | A phase I safety, dose finding and feasibility trial of GD2IL18CART in patients with relapsed or refractory GD2 positive solid cancers | Westfaelische Wilhelms Universitaet Muenster |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Patient underwent treatment with GD2IL18CART in the primary trial prior to enrollment into long-term follow-up.
- Patient and/or caregivers have provided informed consent at any time prior to the first trial-specific assessment
Exclusion criteria 1
- No exclusion criteria are defined for this long-term follow-up trial.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percentage of patients with late-onset adverse reactions (AR), serious adverse events (SAE), serious adverse reactions (SAR) and adverse events of special interest (AESI) including relapse or progression of the underlying disease, life-threatening infections, death due to any cause, new and secondary malignancies
Secondary endpoints 5
- Pediatric patients: Height and weight, Tanner status
- Percentage of patients who relapse or progress since enrollment and rate of surviving patients
- Probabilities of overall survival, disease-free survival
- Duration of response, relapse rate and time to relapse
- Percentage of patients with detectable transgene levels. If results of 2 consecutive years are negative for an individual patient, further sampling will not be continued for this patient.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD10950923 · Product
- Active substance
- GD2IL18CART
- Pharmaceutical form
- INFUSION
- Route of administration
- OTHER USE
- Authorisation status
- Not Authorised
- MA holder
- UNIVERSITAET MUENSTER
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaet Muenster
- Sponsor organisation
- Universitaet Muenster
- Address
- Schlossplatz 2, Schlossbezirk Schlossbezirk
- City
- Muenster
- Postcode
- 48149
- Country
- Germany
Scientific contact point
- Organisation
- Universitaet Muenster
- Contact name
- Prof. Dr. med. Claudia Rössig
Public contact point
- Organisation
- Universitaet Muenster
- Contact name
- Prof. Dr. med. Claudia Rössig
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Medizinische Hochschule Hannover ORG-100024473
|
Hanover, Germany | Other, Laboratory analysis |
| Universitaetsklinikum Muenster AöR ORG-100006212
|
Muenster, Germany | Other, Laboratory analysis |
| Universitaetsklinikum Erlangen AöR ORG-100006207
|
Erlangen, Germany | Other, Laboratory analysis |
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 20 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Universitaetsklinikum Erlangen AöR
Abteilung für Kinder- und Jugendmedizin, Loschgestrasse 15, Innenstadt, Erlangen
Universitaet Muenster
Medizinische Klinik A, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsklinikum Essen AöR
Klinik für Hämatologie und Stammzelltransplantation, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Tuebingen AöR
Kinderklinik, Hoppe-Seyler-Strasse 1, Nordstadt, Tuebingen
Universitaetsklinikum Erlangen AöR
Medizinische Klinik 5 – Hämatologie und Internistische Onkologie, Ulmenweg 18, Innenstadt, Erlangen
Universitaet Muenster
Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsklinikum Essen AöR
Klinik für Kinderheilkunde III, Hufelandstrasse 55, Holsterhausen, Essen
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 | 2025-10-06 | 2025-10-06 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-04 | Germany | Acceptable 2025-08-29
|
2025-09-02 |