A Phase 1 Study of CD19-targeted NEX-T CAR T Cells in Participants with RMS, or PMS, or MG (Breakfree-2)
Research type
Research Study
Full title
A Phase 1, Multicenter, Single-arm, Dose-escalation Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants with Relapsing Forms of Multiple Sclerosis (RMS) or Progressive Forms of Multiple Sclerosis (PMS)
IRAS ID
1009171
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2023-507820-22
Clinicaltrials.gov Identifier
Research summary
This multicentre study will look at whether the treatment called CC-97540 will help people with Multiple Sclerosis (MS) and what the correct dose should be. It is a Phase 1 study, so is the first time this treatment is being given to patients with MS. Patients with relapsing MS (age 18 to 60) or progressive MS (age 18 to 65) will be invited. This study will include about 84 participants worldwide, including about 10 in the UK. If participants meet the eligibility requirements, they will receive CC-97540, there is no placebo, and it is not randomised.
CC-97540 is a CAR-T cell therapy product, which involves taking out one form of immune cells (T-cells) from the blood and adapting them in a lab to better target other immune cells (B cells and plasmablasts) that are not well controlled in MS patients.
Participants will have chemotherapy for 3 days to suppress their immune system before receiving their CC-97540 T cells back by an infusion.
There are 2 parts to this study: Part A will test different amounts of CC-97540 to give to participants to find the dose that is safe and has a positive effect. The dose a participant will receive in Part A will depend on when they join the study. Part B will use the best dose(s) determined from Part A and check if it has the same effect in a larger number of participants. The study has 3 periods: Pre-Treatment (6-8 weeks), Treatment (5 weeks) and Follow-up (24 months). The expected total study duration is up to 27 months (2 years, 3 months). The study will also investigate other questions such as how serious and how often side effects occur with CC-97540, growth and survival of CAR-T cells in the blood, and participant's quality of life. It is sponsored by Celgene (a BMS company).REC name
London - West London & GTAC Research Ethics Committee
REC reference
24/LO/0056
Date of REC Opinion
21 Mar 2024
REC opinion
Further Information Favourable Opinion