CA061-1011: Study Of CD19-CAR T Cells, in Participants with Active SLE (Breakfree-SLE)
Research type
Research Study
Full title
A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants with Active SLE (Including Lupus Nephritis) with Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)
IRAS ID
1011901
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2024-519278-37
Clinicaltrials.gov Identifier
Research summary
This study will test a new treatment called CC-97540, a type of cell therapy, in people with Systemic Lupus Erythematosus (Lupus), including those with lupus affecting the kidneys. Lupus is a serious autoimmune disease where the immune system attacks the body’s own tissues, causing pain, fatigue, and damage to organs. Current treatments often involve long-term use of steroids and other immune-suppressing drugs, which may not work well and may cause serious side effects.
CC-97540 is made from a person’s own immune cells. These cells are collected from the blood, modified in a lab to better target harmful B cells (a type of white blood cell involved in the immune system), and then returned to the body through an infusion.
The main goal of this study is to see if CC-97540 can help people achieve remission from Lupus without further medication. The study will also look at kidney function, quality of life, and how much steroid medication is still needed.
Participants must be at least 16 years old and have active Lupus that has not improved after treatment with glucocorticoids and at least two other immune-suppressing drugs.
Following screening, eligible participants will undergo blood cell collection (leukapheresis). Once the cells come back from the lab, participants will be checked over before receiving a short course of chemotherapy to reduce the number of remaining immune cells (lymphodepletion) followed by the one-time CC-97540 infusion. Treatment will be given in a specialised treatment centre. Participants will need to stay in hospital for 10 days after the infusion and stay close by the hospital for the following 2 weeks. After this 4-week period, participants will enter the follow-up period. They will be monitored for 5 years for safety, disease status, and quality of life. After this, they may enter a separate long-term follow-up study for up to 15 years.REC name
South Central - Oxford A Research Ethics Committee
REC reference
25/SC/0208
Date of REC Opinion
29 Aug 2025
REC opinion
Further Information Favourable Opinion