A phase 2 single arm, open phase study of ADP-A2M4 SPEAR™ T cells
Research type
Research Study
Full title
A Phase 2 Single Arm Open-Label Clinical Trial of ADP-A2M4 SPEAR™ T cells in subjects with Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) (SPEARHEAD 1 STUDY)
IRAS ID
265659
Contact name
Sandra Strauss
Contact email
Sponsor organisation
Adaptimmune LLC
Eudract number
2019-000589-39
Duration of Study in the UK
15 years, 10 months, 14 days
Research summary
This phase 2 study is intended for women and men at least 16 years of age and no more than 75 years who have an advanced soft tissue cancer - Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma (MRCLS) that has grown or not responded to treatment.
The purpose of this study is to test the efficacy of genetically changed T-cells. This study is for participants who have a blood test positive for appropriate HLA-A*02 and have adequate MAGE-A4 protein in tumour. Sixty participants are planned to get the changed T-cells in this study.
The study will take the participant's T-cells, which are a natural type of immune cell in the blood, and send them to a laboratory to be modified. The changed T-cells used in this study will be the participant's own T cells that have been genetically changed with the aim of attacking and destroying cancer cells.
The manufacturing of T cells can take about 45 days to complete. The modified T- cells will be given back to the participant through an intravenous infusion after 4 days of chemotherapy.
Participants will be hospitalised during chemotherapy and at least 1 day after the administration of the modified T-cells. Participants will have regular hospital visits 4 days following infusion and on day 8 after the modified T cell administration and then they will be seen frequently by the Study doctor in the 24 weeks following changed T-cell administration. After that, participants will be seen every two months till the cancer gets worse. If the participants cancer will worsens, they will enter into a long-term follow up for safety monitoring. In long-term follow up, participants will be seen every 6 months by their Study Doctor for the first 5 years after the T cell infusion and annually for the next 10 years(up to a total of 15 years.REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/1365
Date of REC Opinion
5 Dec 2019
REC opinion
Further Information Favourable Opinion