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NOT YET RECRUITING
NCT07897968
PHASE1

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

Sponsor: Universität Münster

View on ClinicalTrials.gov

Summary

This study will test a chimeric antigen receptor (CAR) T-cell treatment combined with bevacizumab in children and young adults with relapsed or refractory neuroblastoma, Ewing sarcoma, or osteosarcoma. The CAR T-cell treatment, called GD2IL18CART, is made from a patient's own T cells. The T cells are genetically modified to recognize GD2, a molecule found on the surface of these cancers, and to release the immune-stimulating protein interleukin-18 (IL-18) when they encounter tumor cells. Bevacizumab is an antibody that blocks vascular endothelial growth factor (VEGF), a protein that affects tumor blood vessels and may make it difficult for immune cells to enter tumors. Combining bevacizumab with GD2IL18CART may therefore help more CAR T cells reach the tumor and improve their antitumor activity. The main goals of this study are to determine whether the combination can be given safely, identify a recommended dose of GD2IL18CART for use with bevacizumab, and look for early evidence of antitumor activity. The study will also examine blood and tumor samples to better understand how the treatment affects CAR T cells and the tumor environment.

Official title: A Phase Ib Safety, Dose Finding and Feasibility Trial of GD2IL18CART Combined With Bevacizumab in Patients With Relapsed or Refractory GD2 Positive Solid Cancers

Key Details

Gender

All

Age Range

1 Year - 25 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2027-10-01

Completion Date

2032-12-31

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

GENETIC

Chimeric Antigen Receptor (CAR) Therapy Infusion

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).

DRUG

Bevacizumab (Avastin)

In combination with GD2IL18CART (IMP1, EU CT 2022-501725-21-00)

Locations (1)

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

Münster, North Rhine-Westphalia, Germany