Clinical trial • Phase I • Oncology

GD2IL18CART for Neuroblastoma | Osteosarcoma | Ewing sarcoma | Advanced breast cancer

Phase I trial of GD2IL18CART for Neuroblastoma | Osteosarcoma | Ewing sarcoma | Advanced breast cancer. 20 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Neuroblastoma | Osteosarcoma | Ewing sarcoma | Advanced breast cancer
Trial Stage
Phase I
Drug Modality
Cell therapy
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
04-07-2025
First CTIS Authorization Date
02-09-2025

Trial design

Phase I trial in Germany.

Target Sample Size
20
Trial Duration For Participant
5810

Eligibility

Recruits 20 paediatric patients.

Vulnerable Population
isVulnerablePopulationSelected: false. Pediatric patients are included; informed consent requirement: "Patient and/or caregivers have provided informed consent at any time prior to the first trial-specific assessment". No assent or additional age-specific consent processes described.

Inclusion criteria

  • {"criterion_text":"- Patient underwent treatment with GD2IL18CART in the primary trial prior to enrollment into long-term follow-up.\n- Patient and/or caregivers have provided informed consent at any time prior to the first trial-specific assessment"}

Exclusion criteria

  • {"criterion_text":"- No exclusion criteria are defined for this long-term follow-up trial."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 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","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Pediatric patients: Height and weight, Tanner status","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of patients who relapse or progress since enrollment and rate of surviving patients","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Probabilities of overall survival, disease-free survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Duration of response, relapse rate and time to relapse","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 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.","definition_or_measurement_approach":"Transgene detection over time with cessation of sampling if two consecutive yearly results are negative for an individual patient."}

Recruitment

Planned Sample Size
20
Recruitment Window Months
190
Consent Approach
"Patient and/or caregivers have provided informed consent at any time prior to the first trial-specific assessment". No additional details on assent, age-specific documents or languages provided.

Geography

Total Number Of Sites
7
Total Number Of Participants
20

Germany

Earliest CTIS Part Ii Submission Date
25-08-2025
Latest Decision Or Authorization Date
02-09-2025
Processing Time Days
8
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Hämatologie und Stammzelltransplantation
Principal Investigator Name
Bastian von Tresckow
Principal Investigator Email
Bastian.vonTresckow@uk-essen.de
Contact Person Name
Bastian von Tresckow
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Medizinische Klinik 5 – Hämatologie und Internistische Onkologie
Principal Investigator Name
Andreas Mackensen
Principal Investigator Email
andreas.mackensen@uk-erlangen.de
Contact Person Name
Andreas Mackensen
Site Name
Universitaet Muenster
Department Name
Klinik für Kinder- und Jugendmedizin - Pädiatrische Hämatologie und Onkologie
Principal Investigator Name
Claudia Rössig
Principal Investigator Email
rossig@ukmuenster.de
Contact Person Name
Claudia Rössig
Contact Person Email
rossig@ukmuenster.de
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Abteilung für Kinder- und Jugendmedizin
Principal Investigator Name
Markus Metzler
Principal Investigator Email
markus.metzler@uk-erlangen.de
Contact Person Name
Markus Metzler
Contact Person Email
markus.metzler@uk-erlangen.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Kinderklinik
Principal Investigator Name
Michaela Döring
Principal Investigator Email
michaela.doering@med.uni-tuebingen.de
Contact Person Name
Michaela Döring
Site Name
Universitaet Muenster
Department Name
Medizinische Klinik A
Principal Investigator Name
Torsten Keßler
Principal Investigator Email
torsten.kessler@ukmuenster.de
Contact Person Name
Torsten Keßler
Contact Person Email
torsten.kessler@ukmuenster.de
Site Name
Universitaetsklinikum Essen AöR
Department Name
Klinik für Kinderheilkunde III
Principal Investigator Name
Stefan Schönberger
Principal Investigator Email
stefan.schoenberger@uk-essen.de
Contact Person Name
Stefan Schönberger

Sponsor

Primary sponsor

Full Name
Universitaet Muenster
Organisation Type
Educational Institution
Country Of Registered Address
Germany

Third parties

  • {"country":"Germany","full_name":"Medizinische Hochschule Hannover","duties_or_roles":"Complementary Research; code 4","organisation_type":"Educational Institution"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Muenster AöR","duties_or_roles":"Complementary Research; code 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Germany","full_name":"Universitaetsklinikum Erlangen AöR","duties_or_roles":"Complementary Research; code 4","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
GD2IL18CART
Active Substance
GD2IL18CART
Modality
Cell therapy
Routes Of Administration
INFUSION
Route
Infusion
Authorisation Status
Non-authorised ATMP (stated: Follow-up of patients treated in phase I (non-authorised ATMP))

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