BMS CAR T-Cell Therapy Shows Potential for ‘Immune Reset’ in Severe Autoimmune Diseases

PRINCETON, NJ — October 27, 2025 — Bristol Myers Squibb (BMS) (NYSE: BMY) today announced highly encouraging updated data from its Phase 1 Breakfree-1 study (NCT05869955) of the investigational CD19-targeted CAR T cell therapy, BMS-986353 (CD19 NEX-T™). The results, presented at the American College of Rheumatology (ACR) Convergence 2025, suggest the potential to induce treatment-free remission in patients with severe, refractory autoimmune disorders.

The data analyzed 71 treated patients across three cohorts: systemic sclerosis (SSc), systemic lupus erythematosus (SLE), and idiopathic inflammatory myopathies (IIM). In a key finding suggesting an “immune reset,” 94% of evaluable patients remained off chronic immunosuppressive therapy at the time of analysis.

Evidence of Deep and Durable Response

Across all three cohorts, the one-time infusion of CD19 NEX-T demonstrated robust CAR T cell expansion, complete B cell depletion, and the re-emergence of a naive B cell phenotype.

Systemic Sclerosis (SSc)

Updated results from the SSc cohort showed unprecedented improvements in patients with SSc-interstitial lung disease (ILD):

• A median relative predicted forced vital capacity (pFVC) increase of 10% from baseline was seen at six months in subjects with ILD—an improvement in lung function not observed with other therapeutic modalities.
• Patients also saw clinically meaningful improvement in skin thickness.

Dr. Dinesh Khanna, Professor and Director of the University of Michigan Scleroderma Program, called the data highly encouraging, stating, “The potential for new treatment approaches to ‘reset’ a patient’s immune system… provides hope for patients living with these chronic diseases.”

Systemic Lupus Erythematosus (SLE)

The SLE cohort (n=32) included patients with severe, refractory disease who had failed a median of seven prior therapies.

• All efficacy-evaluable patients except one achieved resolution of clinical symptoms by six months.
• Disease activity rapidly improved and was sustained for up to 18 months of follow-up.
• 92% of patients remained off SLE-specific immunosuppressive therapies at evaluation.

Idiopathic Inflammatory Myopathies (IIM)

First disclosure of the IIM cohort data (n=13) showed:

• 91% of efficacy-evaluable patients achieved a moderate-major composite assessment of the total improvement score.
• Patients experienced rapid and substantial improvement in muscle strength, with a median increase in the MMT-8 score of 22% at six months.

Safety Profile Consistent with CAR T

The overall safety profile was deemed acceptable and consistent with expectations for CAR T-cell therapies. Most adverse events (AEs) were transient, occurring shortly after infusion and resolving quickly.

• All cytokine release syndrome (CRS) events were low grade in the SSc and IIM cohorts, with one transient Grade 3 event in the SLE cohort.
• Two transient Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) events were reported across SSc and IIM, all resolving completely.

“We are building on this expertise to bring the modality into the new frontier of autoimmune diseases,” said Lynelle B. Hoch, president, Cell Therapy Organization, BMS. “These data demonstrate… the potential of treatment-free remission, which just a few years ago was not thought to be possible for patients with severe autoimmune disorders.”

The CD19 NEX-T therapy pairs the CAR construct used in BMS’s FDA-approved cancer therapy, Breyanzi, with the next-generation NEX-T manufacturing platform, which aims to optimize the production process. BMS is continuing to advance this program, with recruitment ongoing for the Phase 2 Breakfree-SLE study.