A Phase I trial of anti-GD2 CAR transduced T-cells (1RG-CART) v1.
Research type
Research Study
Full title
A Cancer Research UK Phase I trial of anti-GD2 chimeric antigen receptor (CAR) transduced T-cells (1RG-CART) in patients with relapsed or refractory neuroblastoma.
IRAS ID
152527
Contact name
Karen Dyer
Contact email
Sponsor organisation
Cancer Research UK Centre for Drug Development
Eudract number
2013-004554-17
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
This Phase I study is looking at the effects of giving a type of immunotherapy, called 1RG-CART, to patients with relapsed or refractory neuroblastoma. Immunotherapy means treatment that uses the body’s own immune system to attack cancer. 1RG-CART are made by taking immune cells (called T-cells) from the patient’s blood, modifying them in the laboratory (‘transduction’) and then giving them back to the patient. The T-cells have a new gene inserted into them, which hopefully enables them to identify and attack the cancer by recognising and binding to a marker called GD2.
The main aims of the study are to find out:
• If 1RG-CART can be made in the laboratory and given safely to patients.
• The side effects of 1RG-CART and how to treat them.
• If giving chemotherapy first helps the 1RG-CART to survive in the body and proliferate (grow in numbers).
• How well and for how long 1RG-CART survive inside the body.
• Whether 1RG-CART cause tumour shrinkage.Up to 27 patients will be treated in the following groups:
• Group 1 - will receive 1RG-CART alone.
• Group 2 - will receive a chemotherapy drug (cyclophosphamide) for four days before receiving 1RG-CART.
• Group 3 - will receive two chemotherapy drugs (cyclophosphamide and fludarabine) before 1RG-CART. Fludarabine will be given for five days and cyclophosphamide for four days (the two drugs are given together after the first day of fludarabine alone).
• Group 4 - will receive a higher dose of 1RG-CART than Groups 1 to 3. Chemotherapy may or may not be given first, depending on results in the previous groups. Group 4 may not be needed if 1RG-CART survive well in the previous groups.
Additional patients will then be recruited to whichever group shows the best 1RG-CART survival.REC name
London - West London & GTAC Research Ethics Committee
REC reference
15/LO/1510
Date of REC Opinion
4 Dec 2015
REC opinion
Further Information Favourable Opinion