Can Bristol Myers Squibb’s CD19 NEX-T therapy replace lifelong immunosuppression? Early Phase 1 data raises the question

Bristol Myers Squibb (NYSE: BMY) has presented compelling Phase 1 trial results suggesting that its investigational CD19 NEX-T CAR T cell therapy may be capable of inducing durable immune reset in severe autoimmune diseases. The data, disclosed at ACR Convergence 2025, covers 71 patients across three highly refractory disease cohorts—systemic sclerosis, systemic lupus erythematosus and idiopathic inflammatory myopathies. The findings point to a future in which a single infusion of cell therapy could potentially replace the chronic immunosuppressive regimens that currently define care in these conditions.

The announcement marks a significant moment not only for Bristol Myers Squibb but for the entire immunology sector. CAR T therapies have transformed certain blood cancer treatments over the past decade. Extending the same technology beyond oncology and into autoimmune disease represents a structural shift in cell therapy’s therapeutic scope. The Breakfree-1 trial results indicate that such a shift may be realistic, with around 94% of evaluable patients remaining off chronic immunosuppressive therapies at the time of analysis.

This development lands at a strategically important time for Bristol Myers Squibb. The company faces increasing pressure to demonstrate long-term growth beyond legacy oncology and immunology franchises. The emergence of cell therapy as a possible treatment modality in autoimmune disease introduces a new pipeline vector that could meaningfully reshape the company’s long-term positioning.

Why are the Breakfree-1 trial results seen as potentially transformative for autoimmune disease treatment?

The Breakfree-1 Phase 1 study evaluates BMS-986353, an autologous CD19-targeted CAR T cell therapy built on Bristol Myers Squibb’s NEX-T manufacturing platform. The therapy involves collecting a patient’s T cells, re-engineering them to target CD19-expressing B cells and administering a single infusion following lymphodepletion. Unlike conventional therapies used in autoimmune disease, which suppress immune activity continuously, this approach aims to “reset” immune function at the cellular level.

Patients in all three cohorts experienced robust CAR T expansion, sustained B cell depletion and re-emergence of a naïve B-cell profile consistent with immune re-balancing. The fact that nearly all evaluable patients were able to discontinue chronic immunosuppressive medications is a critical signal. Autoimmune diseases such as lupus and systemic sclerosis typically require continuous therapy to control inflammation and prevent organ damage. A one-time intervention that may achieve the same outcomes—or potentially better stability—would represent a paradigm break rather than incremental progress.

The safety profile has been manageable across cohorts. Cytokine release syndrome and neurotoxicity events were primarily low-grade and resolved with standard management. Importantly, the incidence and severity of these events were comparable—or in some cases more favourable—than what is commonly observed in oncology settings. That suggests the therapy may be clinically usable in broader patient populations.

What improvements were seen in systemic sclerosis, and why is this particularly significant?

The systemic sclerosis cohort demonstrated one of the most striking findings. Among patients with interstitial lung disease, a median increase of approximately 10% in predicted forced vital capacity was observed at the six-month mark. This is notable because improvement in lung function is rarely seen in this condition. Systemic sclerosis is progressive, difficult to treat and carries significant morbidity. Observing lung function improvement and reductions in skin thickening after discontinuation of disease-directed therapy represents a signal not commonly seen with currently approved therapies.

The possibility of using a single CAR T infusion to halt or reverse fibrotic disease progression places systemic sclerosis among the autoimmune indications that could experience the most dramatic clinical impact if this therapeutic paradigm holds through later-phase trials.

How did the therapy perform in systemic lupus erythematosus, where treatment burden is high and flares are unpredictable?

The lupus cohort included patients with severe, active disease who had undergone a median of seven prior therapies. Across the Phase 1 data, nearly all patients achieved resolution of symptoms and sustained reductions in disease activity indices. Approximately 92% of patients remained off lupus-specific immunosuppressants at analysis. Considering the cycle of flare-control-flare that defines lupus management, these results suggest the possibility of durable remission that does not depend on lifelong biologics or steroids.

If validated in larger studies, this could influence how clinicians view disease progression timelines, therapy sequencing and even early intervention strategies.

What early signals did the trial show for idiopathic inflammatory myopathies?

Patients in the IIM cohort experienced rapid and meaningful improvement in muscle strength and functional scores. The majority of efficacy-evaluable patients achieved moderate-to-major overall improvement based on standardized myositis scoring criteria. For a disease where muscle degeneration can lead to profound disability, the functional improvements observed—even in heavily pre-treated patients—carry considerable clinical importance.

The response profile suggests that the therapy directly addresses the autoimmune drivers of ongoing muscle tissue damage, rather than merely suppressing inflammation.

How does this study fit into Bristol Myers Squibb’s evolving strategic positioning in cell therapy?

Bristol Myers Squibb is currently one of the only companies with two FDA-approved CAR T therapies targeting distinct antigens. Its NEX-T platform is designed to shorten manufacturing timelines while improving cell quality and consistency. Breakfree-1 is not an isolated study; it is part of a multi-cohort program evaluating cell therapy across autoimmune indications with high unmet need.

This is a strategic expansion rather than an experimental curiosity. It signals the company’s intent to establish leadership at the intersection of cell therapy and immunology—a space likely to become a major growth frontier for the next decade.

What does this mean for investors, given Bristol Myers Squibb’s recent market performance?

Bristol Myers Squibb shares have been under pressure over the past year, reflecting concerns about patent expirations, revenue transitions and competitive pressures in immunology. The stock has been trading near multi-year lows, with many institutional investors categorizing the company as a defensive dividend hold rather than a growth story.

The Breakfree-1 data does not immediately change revenue models because it is still early-stage. However, it does meaningfully shift the long-term narrative. If Bristol Myers Squibb successfully advances CAR T into autoimmune disease, it could reshape its medium- to long-term growth trajectory, open high-value markets and position the company at the forefront of a therapeutic frontier that competitors are only beginning to enter.

For now, sentiment aligns best with a Hold-with-Upside investment posture. Value-oriented investors may see opportunity if Phase 2 and Phase 3 progression remains positive.

What are the most important signals from the Phase 1 Breakfree-1 data that matter for clinicians, investors, and the autoimmune field?

• Phase 1 data show strong early signs of immune reset across three severe autoimmune diseases

• Approximately 94% of evaluable patients remained off chronic immunosuppressive therapy

• Systemic sclerosis cohort showed lung function improvement rarely observed with existing treatments

• Lupus patients demonstrated rapid and sustained reductions in disease activity, with most remaining treatment-free

• Idiopathic inflammatory myopathy cohort saw meaningful gains in muscle strength and functional recovery

• Safety profile consistent with expectations for CAR T therapies, with manageable CRS and ICANS

• Signals a strategic expansion of cell therapy beyond oncology into chronic autoimmune disease landscapes

• Investor sentiment may shift as development progresses, offering possible re-rating potential if clinical outcomes remain strong