Trials Sponsors Conditions Drugs Pricing

Conditions

Neuroblastoma (NBL)Ewing Sarcoma Osteosarcoma

Keywords

CAR T-cell therapyGD2GD2IL18CARTIL-18VEGFVEGF inhibitionpediatric solid tumorsneuroblastomaosteosarcomaEwing sarcomabevacizumab

Outcome Measures

Primary Outcomes (4)

Incidence and severity of adverse events
Incidence and severity of adverse events (AEs), graded according to CTCAE version 6.0
Through 12 months after GD2IL18CART infusion
Dose-limiting toxicities and recommended dose - dose-finding part
Incidence of protocol-defined dose-limiting toxicities (DLTs) and determination of the recommended dose (RD) of GD2IL18CART in combination with bevacizumab using a rule-based small-cohort design
28 days after IMP infusion
Recommended dose of GD2IL18CART in combination with bevacizumab
Determination of the recommended dose (RD) of GD2IL18CART in combination with bevacizumab using a rule-based small-cohort dose-escalation design, based on observed dose-limiting toxicities (DLTs) and protocol-defined dose-escalation and stopping rules.

Study Arms (1)

GD2IL18CART + bevacizumab

EXPERIMENTAL

Participants receive a single intravenous infusion of freshly prepared autologous GD2IL18CART cells in combination with intravenous bevacizumab administered every 3 weeks for up to 5 doses.

Genetic: Chimeric Antigen Receptor (CAR) Therapy InfusionDrug: Bevacizumab (Avastin)

Interventions

Chimeric Antigen Receptor (CAR) Therapy InfusionGenetic

Combination of GD2IL1CART (IMP1, EU CT 2022-501725-21-00) with a monoclonal antibody against vascular endothelial growth factor, bevacizumab (IMP2) to promote effective CAR T-cell accumulation and function within the immunosuppressive tumor microenvironment (TME).

Also known as: GD2IL18CART

GD2IL18CART + bevacizumab

Bevacizumab (Avastin)Drug

Eligibility Criteria

Age1 Year - 25 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Participants must have relapsed and/or refractory neuroblastoma, osteosarcoma, or Ewing sarcoma judged to be incurable with conventional treatment and meet the following disease-specific prior-treatment requirements:
Neuroblastoma: Participants with locoregional recurrence must have received surgery and/or radiotherapy followed by relapse chemotherapy. Participants with metastatic recurrence after initial classification as intermediate risk must have received high-risk therapy. Participants with recurrence after initial classification as high risk must have received relapse chemotherapy alone or combined with immunotherapy.

Sponsors & Collaborators

University Hospital Erlangen
Othercollaborator
Princess Maxima Center for Pediatric Oncology
Othercollaborator

Study Sites (1)

Department of Pediatric Hematology and Oncology, University Children's Hospital Muenster

Münster, North Rhine-Westphalia, 48149, Germany

Related Publications (1)

Fischer-Riepe L, Kailayangiri S, Zimmermann K, Pfeifer R, Aigner M, Altvater B, Kretschmann S, Volkl S, Hartley J, Dreger C, Petry K, Bosio A, von Dollen A, Hartmann W, Lode H, Gorlich D, Mackensen A, Jungblut M, Schambach A, Abken H, Rossig C. Preclinical Development of CAR T Cells with Antigen-Inducible IL18 Enforcement to Treat GD2-Positive Solid Cancers. Clin Cancer Res. 2024 Aug 15;30(16):3564-3577. doi: 10.1158/1078-0432.CCR-23-3157.
PMID: 38593230BACKGROUND

MeSH Terms

Conditions

NeuroblastomaSarcoma, EwingOsteosarcoma

Interventions

Receptors, Chimeric AntigenAutomobilesBevacizumab

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and Epithelial

Study Officials

Claudia Rossig, MD
University Children´s Hospital Münster
PRINCIPAL INVESTIGATOR

Central Study Contacts

Claudia Rossig, MD

CONTACT

00492518347742 rossig@ukmuenster.de

Andreas Mackensen, MD

CONTACT

004991318535954

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SEQUENTIAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 20, 2026

First Posted

October 27, 2026

Study Start

October 1, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

Active solid central nervous system (CNS) metastases or metabolically active metastatic disease in the skull with direct contact to the dura.
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, or paralysis.
History of an additional malignancy other than non-melanoma skin cancer or carcinoma in situ unless disease-free for ≥3 years.
Pre-existing severe lung disease, oxygen requirement of \>28% O2 supplementation, or active pulmonary infiltrates on X-ray.
Cardiac function: fractional shortening \<28% or left ventricular ejection fraction \<50% by echocardiography in pediatric participants (\<18 years); left ventricular ejection fraction \<50% by echocardiography in young adult participants (18-25 years).
Renal function: GFR ≤29 mL/min/1.73 m² by CKD-EPI for participants ≥18 years or creatinine clearance ≤29 mL/min/1.73 m² by Schwartz formula for participants \<18 years.
Liver function: serum bilirubin \>3 times the upper limit of normal (ULN) or AST or ALT \>5 times ULN, unless due to liver infiltration by the underlying malignant disease in the Investigator's estimation.
Hematological function: absolute neutrophil count \<500/µL or platelet count \<50 × 10³/µL.
Presence of any active infection.
Uncontrolled arterial hypertension or history of hypertensive crisis or hypertensive encephalopathy.
Clinically significant proteinuria.
History of gastrointestinal perforation or clinically significant fistula, or a current condition considered to confer a clinically relevant increased risk of gastrointestinal perforation.
Clinically significant bleeding or coagulopathy, including recent clinically significant hemoptysis or pulmonary hemorrhage.
Any history of clinically significant arterial thromboembolic event, including myocardial infarction, cerebrovascular accident, transient ischemic attack, or arterial thrombosis/embolism.
+23 more criteria

GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

GD2IL18CART + bevacizumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Secondary Outcomes (2)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Study Arms (1)

GD2IL18CART + bevacizumab

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Secondary Outcomes (2)

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations