CA097-001 BMS-986403 in subjects with relapsed/refractory CLL or SLL
Research type
Research Study
Full title
A Phase 1, Multicenter, Open-Label Study Of BMS-986403 In Subjects With Relapsed And/Or Refractory Chronic Lymphocytic Leukemia (CLL) Or Small Lymphocytic Lymphoma (SLL)
IRAS ID
1005698
Contact name
Kashif Hussain
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2021-003274-31
Clinicaltrials.gov Identifier
Research summary
Chronic Lymphocytic Leukaemia (CLL) or small lymphocytic lymphoma (SLL) remains incurable for many patients despite recent advances in treatments.
New treatments are urgently needed for these patients.
BMS-986403 is a type of CAR T-cell therapy being investigated to understand how well it works and the side effects in patients with CLL or SLL.
CAR T-cell stands for chimeric antigen receptor T-cell. This is a type of immunotherapy, which works by modifying your body’s immune cells (T-cells) to enable them to target and fight cancer cells.
Patients will need to have received at least 3 different courses of treatment (known as lines) to be eligible for this study. The study will have 2 parts, part A will look at finding the best dose of drug to use. Part B will test how safe and effective that dose is in patients will CLL and SLL. On completion of this study, patients will be followed up for a further 15 years in a separate observational study.
CAR T-cell therapy is a complex and specialised treatment which involves a number of steps and can take several weeks.
T-cells (a type of white blood cell) taken from the patients’ blood, are modified in a lab (genetically engineered) to make CAR T-cells. These CAR T-cell can recognise and target a specific protein on the cancer cells. They are grown in the lab until there are enough CAR T-cells to treat the patient.
CAR T-cells are given to the patient as an infusion. Patients will generally stay in hospital for at least two weeks afterwards to be monitored for side effects.
This study is being funded by Bristol Myers Squibb and affiliated companies and will take place in 4 centres across the UK (England) and other sites across the world.REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0243
Date of REC Opinion
21 Oct 2022
REC opinion
Further Information Favourable Opinion