drugset / Trial / NCT04539366

Testing a New Immune Cell Therapy, GD2-Targeted Modified T-cells (GD2CART), in Children, Adolescents, and Young Adults With Relapsed/Refractory Osteosarcoma and Neuroblastoma, The GD2-CAR PERSIST Trial

NCT04539366 ↗

Phase 1 Suspended 67 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial investigates the side effects and determines the best dose of an immune cell therapy called GD2CART, as well as how well it works in treating patients with osteosarcoma or neuroblastoma that has come back (relapsed) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this trial will come from the patient and will have a new gene put in them that makes them able to recognize GD2, a protein on the surface of tumor cells. These GD2-specific T cells may help the body's immune system identify and kill GD2 positive tumor cells.

Timeline

Start
2022-01-25
Primary completion
2040-12-31
Completion
2040-12-31

Outcome

Outcome not reported

Stopped: “Other - review of safety data”

Drugs

EvaluationDrugModalityDoseRoute
Subject GD2-CAR-expressing Autologous T-lymphocytes Cell therapy — Intravenous
Background Cyclophosphamide Other / unclassified — Intravenous
Background Fludarabine Small molecule — Intravenous