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

NCT02761915 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-08-17

Study results available
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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.

Conditions

  • Relapsed or Refractory Neuroblastoma

Interventions

OTHER

Leukapheresis

DRUG

Cyclophosphamide

DRUG

Fludarabine

GENETIC

1RG-CART

Sponsors & Collaborators

Principal Investigators

  • John Anderson, Prof · University College London Institute of Child Health & Great Ormond Street Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02761915 on ClinicalTrials.gov