CA061-1005: Study of CD-19-CAR T in participants with active SSc
Research type
Research Study
Full title
A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants with Active Systemic Sclerosis (Breakfree-SSc)
IRAS ID
1013496
Contact name
GSM-CT Representative
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2025-524337-11
Clinicaltrials.gov Identifier
Research summary
Systemic sclerosis (SSc) is an autoimmune disease in which the body’s immune system mistakenly attacks healthy tissues, causing thickening of the skin and damage to organs such as the lungs and muscles. Many people with SSc develop interstitial lung disease (ILD), a serious condition that makes breathing difficult and can greatly affect daily life. Current treatments may slow the disease but often do not stop it from progressing, so better options are urgently needed. BMS 986353 (or zola-cel) is a new treatment called chimeric antigen receptor (CAR) T cell therapy. It uses the patient’s own immune cells, which are collected and modified so they can find and remove harmful B cells that contribute to SSc. This therapy is designed to “reset” the immune system and potentially improve symptoms without the need for long term immune suppressing medicines. Early studies in autoimmune diseases suggest that BMS 986353 have beneficial effects.
This study will compare zola-cel with three commonly used treatments - rituximab, tocilizumab, or nintedanib - in adults with active SSc and ILD who have not improved after at least one of these therapies. Participants will be randomly assigned to receive either zol-cel (Arm A) or one of the comparator treatments (Arm B). In Arm A participants will have T cells collected and will receive short-term chemotherapy (lymphodepletion) to lower their white blood cell count before receiving zola-cel. This step helps prevent the body from removing the infused CAR-T cells, so the treatment can work properly. Participants in Arm B will receive rituximab, tocilizumab, or nintedanib, and some may later be offered BMS 986353 if their disease worsens. Study assessments include physical and neurological exams, lung tests, skin evaluations, scans, ECG, vital signs, blood tests, and health questionnaires. The study duration is up to 36 months.REC name
London - West London & GTAC Research Ethics Committee
REC reference
26/LO/0238
Date of REC Opinion
25 Jun 2026
REC opinion
Further Information Favourable Opinion