Bristol Myers starts Breakfree-SLE, a Phase 2 study of zola-cel in hard-to-treat lupus

Bristol Myers Squibb/Zola-cel (BMS-986353)

BMS began a single-arm Phase 2 study of zola-cel in people with active lupus, including lupus nephritis, whose disease did not respond to steroids and at least two immune-suppressing drugs. About 89 patients are planned, with main results expected around 2028.

• Run by Juno Therapeutics, a BMS company; open-label, one treatment group.
• Estimated primary completion: May 2028.
• Listed as active but no longer recruiting in the Aug 2026 registry update.