Zola-cel Phase 1: 94% of evaluable autoimmune patients stay off long-term immune drugs

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

At ACR Convergence 2025, BMS reported Breakfree-1 results for 71 patients with lupus, scleroderma or inflammatory muscle disease. CAR-T cells expanded, B cells were fully depleted and later came back in a naive form, and 94% of evaluable patients remained off chronic immune-suppressing drugs. Side effects were mostly mild cytokine release, with a few short-lived severe neurological events.

• Lupus: all but one evaluable patient saw symptoms resolve; 92% stayed off lupus-specific immune drugs.
• Inflammatory muscle disease: 91% had a moderate or major response.
• Scleroderma: median 10% relative gain in predicted lung capacity at six months (6 patients).
• Severe (grade 3) neurological events: two in scleroderma, one in myositis, all resolved within five days.