ALPHA2
Research type
Research Study
Full title
A single-arm, open-label, phase 1/2 study evaluating the safety, efficacy, and cellular kinetics/pharmacodynamics of ALLO-501A, an anti-CD19 allogeneic CAR T cell therapy, and ALLO-647, an anti-CD52 monoclonal antibody, in subjects with relapsed/refractory large B-cell lymphoma (LBCL)
IRAS ID
1007378
Contact name
Shalini Gidwani
Contact email
Sponsor organisation
Allogene Therapeutics Inc.
Eudract number
0000-000000-00
Clinicaltrials.gov Identifier
Research summary
With a 0.8% lifetime risk, large B cell lymphoma (LBCL) is the most common aggressive lymphoma. Although chemotherapy cures most of patients, the disease comes back (relapses) or never clears (is refractory) in up to 40% of patients. The outlook in these cases is poor, particularly if they cannot tolerate intense treatment, with an average survival of 6 months. It is therefore important to investigate new therapies for these patients.
In this study, two experimental medications, ALLO-501A and ALLO-647, are being studied for their potential to treat relapsed or refractory (R/R) LBCL. ALLO-501A is a chimeric antigen receptor (CAR) T cell that targets cells bearing CD19. T lymphocytes are cells of the immune system specialised in clearing tumours and viruses. By genetic manipulation, T lymphocytes become CAR T cells directed against cells with CD19, a protein that is present in almost all cases of LBCLs and absent in other tissues. This makes this CAR T active against LBCL while minimising the risk collateral damage.
ALLO-647 is a monoclonal antibody that targets the human CD52 protein. Monoclonal antibodies are laboratory-made molecules that mimic the immune system's ability to fight harmful substances. CD52 is a protein on the surface of T lymphocytes, cells that cause host rejection during transplants, including those of CAR-T cells. In this study, LBCL patients will first receive ALLO-647, with fludarabine and cyclophosphamide, to numb the immune system and decrease the chance of ALLO-501A rejection.
About 100 participants with R/R LBCL across approximately 50 sites will enrol in this study, and their participation will last about 5 years. Participants will receive the lymphodepletion regimen over three days and will then receive ALLO-501A. They will enter a follow-up period of two months with frequent visits to the study site, followed by less frequent visits for up to 5 years after receiving ALLO-501A. This study is funded by Allogene Therapeutics
REC name
North East - York Research Ethics Committee
REC reference
23/NE/0116
Date of REC Opinion
25 Aug 2023
REC opinion
Further Information Favourable Opinion