Bristol Myers Squibb’s CD19 NEX-T therapy shows 94% off immunosuppressants in early Phase 1 results

Bristol Myers Squibb (NYSE: BMY) has unveiled early data from its Phase 1 Breakfree-1 study evaluating CD19 NEX-T, an investigational autologous CAR T cell therapy, in patients with three chronic, refractory autoimmune diseases. The results, presented at the American College of Rheumatology (ACR) Convergence 2025 conference in Chicago, offer the first multi-cohort signal of what the American biopharmaceutical company calls a potential “immune reset.” Among the 71 treated patients across the systemic sclerosis (SSc), systemic lupus erythematosus (SLE), and idiopathic inflammatory myopathies (IIM) cohorts, 94% of those evaluable remained off chronic immunosuppressive therapy at the time of analysis.

These findings, while preliminary, have immediate implications not just for autoimmune disease treatment but also for how the market perceives Bristol Myers Squibb’s pipeline value, cell therapy expansion strategy, and potential to reposition its stock performance amidst patent cliff headwinds and oncology saturation.

CD19 NEX-T combines the CAR construct used in Breyanzi (lisocabtagene maraleucel), the company’s FDA-approved CAR T for hematologic malignancies, with a next-generation manufacturing platform designed for faster and more consistent production. The therapy is being investigated in an ongoing Phase 1 program for its ability to induce immune system rebalancing with a single infusion.

What makes the Breakfree-1 results clinically significant across SSc, SLE, and IIM?

The Breakfree-1 trial is evaluating BMS-986353, a CD19-targeted CAR T cell therapy, in cohorts of patients who have exhausted conventional treatment options for their autoimmune diseases. The study includes systemic sclerosis patients with interstitial lung disease, individuals with severe systemic lupus erythematosus unresponsive to multiple therapies, and idiopathic inflammatory myopathies patients with debilitating muscle and skin involvement. The therapy involves a five-day manufacturing process and a one-time infusion following lymphodepletion.

In the systemic sclerosis cohort, 26 patients were treated, and 19 were evaluable for efficacy. A subgroup of patients with interstitial lung disease showed a median relative predicted forced vital capacity increase of 10% at six months. No other therapy in SSc-ILD has historically demonstrated this level of pulmonary function improvement. Additionally, reductions in skin thickness were observed across patients, with adverse events largely mild and quickly resolved. The safety profile was consistent with expectations from existing CAR T therapies, with all cytokine release syndrome (CRS) events being low grade and resolving within two days. Two transient grade 3 neurotoxicity (ICANS) events resolved fully within five days.

In the systemic lupus erythematosus cohort, 32 patients were treated across two dose levels, with 26 patients receiving the Phase 2 recommended dose. This group had severe, active disease with a median of seven prior lupus-directed treatments. At six months, nearly all efficacy-evaluable patients demonstrated resolution of clinical symptoms, substantial reductions in disease activity index scores, and marked improvements in physician-assessed disease progression. As of the interim readout, 92% of patients remained off immunosuppressive therapy. Safety remained manageable, with transient low-grade CRS observed in most patients and no high-grade neurotoxicity events reported at the recommended dose.

The idiopathic inflammatory myopathies cohort represents the first disclosure of early data. Among 13 patients treated, 11 were efficacy-evaluable, with 91% achieving a composite response based on Myositis Response Criteria. Notably, 64% had a major response and 27% a moderate response. Muscle strength improved rapidly, with a median increase of 17% in MMT-8 scores at three months and 22% at six months. Safety events occurred mostly within 29 days of infusion and were managed effectively.

Across all cohorts, the observed re-emergence of naive B cell phenotypes following B cell depletion suggests that the therapy does more than suppress disease activity—it may facilitate immune system reconstitution. This “reset” potential underpins the future promise of CAR T in autoimmune medicine.

Why is Bristol Myers Squibb pursuing CAR T in immunology and how does it affect long-term growth?

For years, Bristol Myers Squibb has been a leader in hematologic CAR T therapy, with Breyanzi and Abecma achieving market approvals. However, commercial CAR T therapy has been constrained by complex logistics, high manufacturing costs, and intense competition. The move into autoimmune disease is not just scientific—it is strategic. Autoimmune indications like lupus, myositis, and systemic sclerosis represent large, chronic, underserved markets where existing therapies often require lifelong immunosuppression.

By applying its cell therapy infrastructure to autoimmune targets, Bristol Myers Squibb could dramatically expand its total addressable market and redefine treatment models. The company’s NEX-T platform also reduces manufacturing time to five days, improving scalability. This gives the company a first-mover advantage in a field where “resetting” immune systems with one-time cell therapy was until recently unthinkable.

From an institutional sentiment perspective, this move aligns with investor appetite for durable, platform-driven value. With its oncology growth facing increasing biosimilar erosion and generic threats, Bristol Myers Squibb’s pivot to autoimmune applications offers a new storyline that appeals to long-term growth-focused investors.

How is Bristol Myers Squibb’s stock performing and what does sentiment indicate post-data release?

Bristol Myers Squibb shares closed at USD 43.83 on October 24, 2025, near the lower end of its 52-week range. The stock has underperformed broader pharmaceutical indices over the past 12 months, reflecting concerns over upcoming loss of exclusivity events, declining Revlimid sales, and a lack of near-term blockbuster launches.

However, sentiment toward the company may be shifting. While the market reaction to the ACR data was muted on the surface, institutional investors appear to be reevaluating the pipeline’s long-term potential. Buy-side commentary in recent days has highlighted the depth of the company’s immunology portfolio and the emergence of cell therapy as a cross-cutting strategic pillar.

Analysts point to an opportunity for rerating if the company successfully executes on Phase 2 and 3 expansions and demonstrates manufacturing viability at commercial scale. With Breakfree-SLE Phase 2 enrollment ongoing and a robust ACTioN academic collaboration network supporting the program, forward momentum is building.

How will regulatory pathways, durability of remission, manufacturing scalability and real‑world payer acceptance determine the long‑term viability of CD19 NEX‑T in autoimmune diseases?

Despite the promising nature of the Breakfree-1 results, multiple challenges remain. As a Phase 1 study, Breakfree-1 involves relatively small patient cohorts and lacks randomization. Durability of response remains an open question, particularly beyond the 12-month horizon. Regulatory frameworks for cell therapy in autoimmune diseases are still evolving, and it is unclear how agencies will view endpoints like immune reset versus traditional symptom suppression.

There are also operational challenges. The ability to scale manufacturing under the NEX-T platform and ensure cost-effective delivery for autoimmune indications will be critical. CAR T therapies remain expensive, and payers will demand robust durability data to justify costs in chronic disease settings.

Key upcoming milestones include the full enrollment and interim data from the Phase 2 Breakfree-SLE trial, potential additional cohorts in diseases like rheumatoid arthritis, and long-term safety monitoring across existing cohorts. Updates on manufacturing capacity, pricing models, and real-world use case pilots will also influence investor sentiment in the next 12–18 months.

Could CD19 NEX-T cell therapy become the next blockbuster in immunology?

If the trends observed in Breakfree-1 are replicated and extended into larger Phase 2 and 3 trials, Bristol Myers Squibb could emerge as the first biopharmaceutical firm to commercialize CAR T therapy for autoimmune disease. This would mark a historic turning point in immunology and potentially create a multi-billion-dollar annual revenue stream. The company’s claim that “treatment-free remission” could become a standard of care—once unimaginable—no longer feels like a stretch.

Institutional analysts are already beginning to model potential scenarios. If CD19 NEX-T is approved in even a single autoimmune indication with 20,000 eligible patients annually in the U.S. alone, pricing at oncology-like levels could yield over USD 2 billion in peak revenue. Add global uptake and multiple indications, and the upside may rival or exceed Bristol Myers Squibb’s earlier oncology blockbusters.

That said, risks around trial scalability, reimbursement, and manufacturing logistics will weigh heavily until late-stage validation is achieved. For now, Breakfree-1 offers compelling clinical proof-of-concept and a bold reimagining of what CAR T can do.

Key takeaways: What are the most important clinical, strategic, and stock market signals from Bristol Myers Squibb’s Breakfree‑1 CAR T trial?

• Bristol Myers Squibb presented early Phase 1 data from the Breakfree‑1 study at ACR Convergence 2025, evaluating CD19 NEX‑T CAR T cell therapy in three autoimmune indications: systemic sclerosis (SSc), systemic lupus erythematosus (SLE), and idiopathic inflammatory myopathies (IIM).
• Among 71 treated patients across all cohorts, 94% of efficacy-evaluable patients remained off chronic immunosuppressive therapy at the time of analysis, signaling potential for immune reset rather than temporary suppression.
• In the systemic sclerosis cohort, patients with interstitial lung disease showed a 10% median increase in predicted forced vital capacity at six months—an unprecedented outcome not observed with prior therapies.
• The lupus cohort (median of 7 failed prior therapies) demonstrated rapid, sustained reductions in disease activity scores, with 92% of patients off SLE-specific treatments by six months.
• In idiopathic inflammatory myopathies, 91% of efficacy-evaluable patients achieved moderate to major responses, with muscle strength improving up to 22% at six months post-infusion.
• Safety profiles were acceptable across all cohorts, with most cytokine release syndrome and neurotoxicity events being low grade, transient, and quickly managed under standard protocols.
• CD19 NEX‑T is based on the Breyanzi CAR construct and manufactured using a next-generation five-day process designed to improve scalability and cost-efficiency for broader autoimmune indications.
• The company’s stock (NYSE: BMY) closed at USD 43.83 on October 24, 2025, near 52-week lows, but institutional sentiment is warming as this program presents a potential new growth engine beyond oncology.
• Key investor watchpoints include upcoming Phase 2 data from the Breakfree-SLE trial, long-term durability results, regulatory clarity for autoimmune CAR T pathways, and payer models for reimbursement.
• If successful, Bristol Myers Squibb’s CD19 NEX‑T program could usher in a new treatment era—transforming severe autoimmune diseases from chronic conditions to immune-resettable syndromes.