drugset / Trial / NCT02761915

A Phase I Trial of Anti-GD2 T-cells (1RG-CART)

NCT02761915

Phase 1 Completed 17 enrolled Cancer Research UK
Non-randomizedSequentialOpen-labelTreatment

Summary

The purpose of this first in human study is to determine the safety and feasibility of 1RG-CART therapy in patients with relapsed or refractory neuroblastoma. 1RG-CART therapy is a novel immunotherapy under investigation in which patients have their T-cells (a type of white blood cell) collected and modified in the laboratory, before they are given back to the patient. The T-cells are modified to express a chimeric antigen receptor (CAR) which targets disialoganglioside (GD2), a marker expressed on the surface of neuroblastoma cells.

Timeline

Start
2016-02-29
Primary completion
2020-12-16
Completion
2020-12-16

Drugs

EvaluationDrugModalityDoseRoute
Subject 1RG-CART Cell therapy 1e+07 unknown Intravenous
Subject 1RG-CART Cell therapy 1e+08 unknown Intravenous
Subject 1RG-CART Cell therapy 5e+08 unknown Intravenous
Subject 1RG-CART Cell therapy 1e+09 unknown Intravenous
Subject Cyclophosphamide Other / unclassified 300 mg/m2
Subject Fludarabine Small molecule 25 mg/m2

Indications

No indication recorded.