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Healthy-donor CD19-targeted allogeneic CAR T-cell therapy for severe, treatment-resistant autoimmune diseases

A Phase 1, Multicenter, Open-label Study of BMS-986515, Healthy Donor Allogeneic CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases

Phase 1 Interventional Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · NCT07115745

This will test whether an infusion of healthy-donor CD19-targeted CAR T cells is safe and can help people with severe, treatment-resistant autoimmune diseases such as lupus, inflammatory myopathy, or systemic sclerosis.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment125 (estimated)
Ages18 Years and up
SexAll
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company Industry-sponsored
Drugs / interventionsCAR-T, CART
Locations28 sites (Boston, Massachusetts and 27 other locations)
Trial IDNCT07115745 on ClinicalTrials.gov

What this trial studies

This Phase 1, open-label trial gives a single or escalating dose of BMS-986515, an allogeneic CD19-directed CAR T-cell product derived from healthy donors, to participants with severe, refractory autoimmune diseases. Participants receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) before infusion and may receive tocilizumab for cytokine release management as needed. The primary goals are to determine safety, tolerability, and the optimal dose, with secondary measures of preliminary clinical activity and biomarker changes such as autoantibody levels. Enrollees must have active, refractory disease despite prior steroids and immunosuppressants and will be followed closely at participating centers for inpatient and outpatient monitoring.

Who should consider this trial

Good fit: Ideal candidates are adults with severe, active autoimmune disease (for example SLE, idiopathic inflammatory myopathy, or systemic sclerosis) refractory to steroids and prior immunosuppressive treatments and, where applicable, positive for disease-associated autoantibodies.

Not a fit: Patients with mild or well-controlled disease, conditions not primarily driven by CD19+ B cells, or significant uncontrolled infections or organ failure are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could eliminate or greatly reduce autoantibody-producing B cells and produce durable remissions for patients who have failed standard therapies.

How similar studies have performed: Autologous CD19 CAR T-cell treatments have produced dramatic remissions in small case reports of refractory autoimmune diseases, but healthy-donor allogeneic CD19 CAR T-cell therapy is a newer approach with limited prior clinical data.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

\- Systemic lupus erythematosus (SLE) population:.

i) Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR).

ii) Participant must be positive for at least one of the following antibodies at screening: anti-nuclear antibody, anti-dsDNA, anti-histone, anti-chromatin or anti-Sm antibody.

iii) Inadequate response or intolerance to steroids and immunosuppressive therapies.

iv) Participants must have active disease at screening.

\- Inflammatory myopathy (IIM) population:.

i) Participants meeting the 2017 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.

ii) Participants must meet criteria for with severe, refractory IIM. iii) Participants who had inadequate response to steroids and prior immunosuppressive therapies.

iv) Evidence of active disease.

\- Systemic sclerosis (SSc) population:.

i) Participant must fulfill the 2013 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis.

ii) Inadequate disease response or intolerance to prior therapies. iii) Participants diagnosed with progressive systemic sclerosis including skin disease and/or interstitial lung disease.

\- Rheumatoid arthritis (RA) population:.

i) Participants with difficult to treat RA. ii) Participants with a diagnosis of RA meeting 2010 ACR/EULAR criteria. iii) Rheumatoid arthritis disease activity at screening and baseline visit. iv) Inadequate disease response or intolerance to standard of care therapy.

Exclusion Criteria

\- All participants:.

i) Any other systemic autoimmune disease. ii) Pregnant or nursing women. iii) Active hepatitis B, C or HIV. iv) Prior history of malignancies. v) Uncontrolled or active infection. vi) History of certain cardiovascular conditions within 6 months prior to screening.

vii) Previous CAR-T cell therapy. viii) Significant lung impairment. ix) Inadequate organ function. x) Active, clinically significant, central nervous system (CNS) disorders.

* SLE population:.

  i) Participants who have SLE because of drugs or have other autoimmune diseases along with SLE.
* IIM population:.

  i) Participants who have other forms of myopathies other than IIM. ii) Severe muscle damage.
* SSc population:.

  i) People who have high blood pressure in the arteries of the lungs caused by SSc, which needs regular treatment to keep it under control.

ii) Rapidly deteriorating SSc, or history of severe kidney disease.

* RA population:.

  i) People who have additional autoimmune diseases along with RA.
* Other protocol-defined inclusion/exclusion criteria apply.

Where this trial is running

Boston, Massachusetts and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Refractory Autoimmune DiseasesCAR-TCell TherapyAutoimmune diseaseSystemic lupus erythematosusidiopathic inflammatory myopathysystemic sclerosisrheumatoid arthritis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.