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A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis

Study acronym: Breakfree-SSc
StatusNot Yet Recruiting
PhasePhase 3
Started2027-02-03
View on ClinicalTrials.gov ↗

Amendment history

2026-07-31
Study Status, Contacts/Locations v5
Trial status changed: Recruiting → Not Yet Recruiting
Study sites56 entries, revised
LocalCleveland Institution - 0122Clinic
2026-06-12
Study Status, Contacts/Locations v4
Start date2026-05-29→2026-08-29
Study sites55→56
2026-05-13
Study Identification, Study Status, Study Description, Contacts/Locations v3
Recruitment opened
Start date2026-04-30→2026-05-29
Study sites54→55
Study description+103 characters
Participants in Arm B may receive BMS-986353 following confirmation of progression on standard of care.
Study titlerevised
A Study to Compare the Efficacy and Safety of BMS-986353 (ZolacaptageneZolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
2026-03-04
Study Status, Contacts/Locations v2
Study sites51→54
2026-02-02
Study Status, Contacts/Locations, IPDSharing, References v1
Start date2026-04-15→2026-04-30
Study sites16→51
2026-01-09
Original filing
The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis
Trial Details
NCT Number NCT07335562
Lead Sponsor Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Collaborators: Celgene Corporation
Conditions Systemic Sclerosis
Enrollment 92 participants
Start Date 2027-02-03
Primary Completion 2028-11-14 (estimated)
Study Completion 2030-11-11 (estimated)
Updated on ClinicalTrials.gov 2026-09-18