Trials Sponsors Conditions Drugs Pricing

Conditions

Neuroblastoma Ewing sarcoma Osteosarcoma

Outcome Measures

Primary Outcomes (3)

Overall incidence and severity of AEs (CTCAE version 5.0)
Dose-finding part: RD of GD2IL18CART based on the maximum tolerated dose (MTD) selected by the Bayesian Optimal Interval (BOIN) Design decision rules (posterior DLT estimate closest to target toxicity, i.e. 20%) until day 28 after GD2IL18CART and on the basis of safety and efficacy.
Dose extension part: Overall response rate (ORR) defined as the rate of complete (CR) or partial (PR) remissions at week 12 by imRECIST.

Secondary Outcomes (5)

In vivo persistence/immune function of GD2IL18CART
Proportion of patients for whom a GD2IL18CART product can be generated
Best response
Duration of response, relapse rate and time to relapse
Disease-free and overall survival at 1 year

Interventions

TOCILIZUMAB Type not reported

FLUDARABINE Type not reported

CYCLOPHOSPHAMIDE Type not reported

Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Child (0-17), Older Adult (65+)

You may qualify if:

Male or female patients must have a diagnosis of relapsed and/or refractory (r/r) neuroblastoma, Ewing sarcoma, osteosarcoma or advanced breast cancer, judged to be incurable with conventional treatment.  Among patients with advanced breast cancer,: ‐ patients with hormone receptor positive disease must have exhausted all endocrine therapy options including a combination with a CDK4/6 inhibitor and chemotherapy must not be a reasonable therapy option, ‐ patients with HER2 positive disease: Patients should have received Trastuzumab-Emtansin (T-DM1) and/or T-DXd in second line after a HER2 directed antibody in the (neo)adjuvant setting or in first line therapy, ‐ patients with triple negative disease must have received at least 2 prior lines of chemotherapy including Sacituzumab-Govitecan in the metastatic setting, and patients with combined positive score (CPS) >10 and/or immune cell score (IC)  1% should have received an immune checkpoint inhibitor previously.  For neuroblastoma, patients with locoregional recurrence must have received surgery and/or radiotherapy followed by relapse chemotherapy. Patients with metastatic recurrence after initial classification as intermediate risk must have received high risk therapy. Patients with recurrence after initial classification as high risk must have received relapse chemotherapy alone or combined with immunotherapy.  Patients with Ewing sarcoma must have received front-line therapy and at least one prior line of relapse chemotherapy according to standard regimens (alkylating agents in combination with topoisomerase inhibitors; irinotecan with temozolomide; gemcitabine and docetaxel; high-dose ifosfamide; carboplatin with etoposide. Patients with an isolated lung relapse must have received pulmonary irradiation either during frontline or relapse therapy.  Patients with osteosarcoma must have received front-line therapy and at least one prior line of relapse chemotherapy (alkylating agents and/or etoposide and/or carboplatin or gemcitabine and docetaxel). Patients with an isolated relapse manifestation (lung metastasis or local relapse) must have unresectable disease.

Sponsors & Collaborators

Universitaet Muenster
Otherlead

Study Sites (7)

Universitaetsklinikum Erlangen AöR

Erlangen, 91054, Germany

Markus Metzler004991318539307 markus.metzler@uk-erlangen.de

Universitaet Muenster

Muenster, 48149, Germany

Thorsten Keßler00492518347602 torsten.kessler@ukmuenster.de

Universitaetsklinikum Tuebingen AöR

Tuebingen, 72076, Germany

Peter Lang004970712985770

Central Study Contacts

Prof. Dr. med. Claudia Rössig

00492518347787 rossig@ukmuenster.de

Study Design

Study Type: interventional
Phase: phase 1

Study Record Dates

First Submitted

December 12, 2023

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: 2022-501725-21-00
Data provider: European Medicines Agency (EMA)
Normalization version: ctis-v1

Open registry record

Source retrieved: 2026-10-30 03:15:49 UTC

Locations

DE(7)

You may not qualify if:

Active solid central nervous system (CNS) metastases
Pregnant or breast-feeding females
Concurrent or recent prior therapies: o High-dose chemotherapy with autologous stem cell transplantation or requiring autologous stem cell rescue or anticancer biologicals (e.g. mifamurtide, interferons) or radiation therapy or major surgery within 30 days prior to leukapheresis o CAR T cells within 3 months prior to leukapheresis o Checkpoint inhibitors within less than 2 half lives prior to apheresis o Neuroblastoma patients who have relapsed after allogeneic or haploidentical stem cell transplantation must be at least 100 days posttransplant, with no evidence of GVHD and not taking immunosuppressive agents for at least 30 days prior to leukapheresis. o I131 MIBG therapy (neuroblastoma) or other targeted radionuclide therapy must be completed at least 3 months prior to apheresis. o GD2-specific antibody therapy with dinutuximab beta or naxitamab within 40 days (5 half lives) o Antiproliferative chemotherapies, epigenetic agents, antibody drug conjugates or antibodies targeting GD2 or alternative antigens (e.g. herceptin)alternative antigens than GD2 or epigenetic agents within 3 weeks prior to leukapheresis o Immunosuppressive agents other than steroids within 2 weeks prior to leukapheresis o Short-acting molecularly targeted agents (kinase inhibitors) within 7 days prior to leukapheresis o Systemic corticosteroids with the exception of physiologic replacement dosing within 7 days prior to leukapheresis o Live vaccines within 30 days prior to leukapheresis
Hypersensitivity against any drug or its ingredients/impurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory preparative chemotherapy, pre-medication for infusion, rescue medication/salvage therapies for treatment related toxicities
Contraindication of trial related procedures as judged by the Investigator, e.g. tumor biopsy
Female patients of child-bearing potential not willing to practice a highly effective form of birth control from the time of signing the informed consent form and for 12 months after dosing the IMP
Male patients of fathering potential not willing to practice a highly effective form of birth control from from the time of signing the informed consent form and for 12 months after dosing the IMP
Concurrent participation in another interventional trial that could interact with this trial, e.g. CAR T trials
Cerebral dysfunction, legal incapacity of adult patients; Committal to an institution on judicial or official order
Current autoimmune disease or history of autoimmune disease with potential CNS involvement
Active clinically significant CNS dysfunction (including but not limited to uncontrolled seizure disorders, cerebrovascular ischemia or hemorrhage, dementia, paralysis)
History of an additional malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease free for ≥3 years
Pulmonary function: Patients with pre-existing severe lung disease or an oxygen requirement of >28% O2 supplementation or active pulmonary infiltrates on X-ray
Cardiac function: Pediatric patients: fractional shortening <28% or left ventricular ejection fraction <50% by echocardiography, adult patients: left ventricular ejection fraction <50% by echocardiography
Renal function: GFR ≤29 mL/min/1.73 m2 by CKD-EPI for patients ≥18 yrs or creatinine clearance ≤29 mL/min/1.73 m2 by Schwartz formula for patients <18 yrs of age
+4 more criteria

A phase I safety, dose finding and feasibility trial of GD2IL18CART in patients with relapsed or refractory GD2 positive solid cancers

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

You may not qualify if:

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (5)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (7)

Central Study Contacts

Study Design

Study Record Dates

Source record

Locations

You may not qualify if: