A Phase 1 interventional study of BMS-986515 and Fludarabine in Refractory Autoimmune Diseases, sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. Recruiting at 28 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-14.
Sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company (part of Bristol-Myers Squibb) · Phase 1, Interventional, and Treatment
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory autoimmune diseases.
802 studies on the registry are indexed under Autoimmune Diseases; 271 are open to participants now.
This study's planned enrollment of 125 is above the median of 40 across 541 interventional studies indexed under Autoimmune Diseases.
Browse Autoimmune Diseases studies →Juno Therapeutics, Inc., a Bristol-Myers Squibb Company is the lead sponsor of 17 studies on the registry; 12 are open to participants now.
First submitted after Juno Therapeutics, Inc. became part of Bristol-Myers Squibb.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 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 and 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, 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 disease. ii) Pregnant or nursing women. iii) Active , C or . iv) Prior history of . 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, , 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Genetic: BMS-986515 · Drug: Fludarabine · Drug: Cyclophosphamide · Drug: Tocilizumab
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Number of participants with treatment-emergent adverse events (TEAEs)
All participants
Time frame: Up to 24 months post BMS-986515 infusion
Number of participants with serious AEs (SAEs)
All participants
Time frame: Up to 24 months post BMS-986515 infusion
Number of participants with AEs of special interest (AESIs)
All participants
Time frame: Up to 24 months post BMS-986515 infusion
Number of participants with laboratory abnormalities
All participants
Time frame: Up to 24 months post BMS-986515 infusion
Number of participants with Dose-Limiting Toxicities (DLTs)
All participants
Time frame: Up to 24 months post BMS-986515 infusion
Number of participants with DLTs that occur during the DLT evaluation period
All participants
Time frame: 28 days post-BMS-986515 infusion
Maximum observed concentration (Cmax)
All participants
Time frame: Up to 2 years
Area under the concentration-time curve (AUC)
All participants
Time frame: Up to 2 years
Time of maximum observed concentration (Tmax)
All participants
Time frame: Up to 2 years
Number of participants with interstitial lung disease (ILD) with no worsening of pulmonary function from baseline to Week 24
All participants
Time frame: Up to 2 years
Number of participants with a humoral immune response (anti-therapeutic antibodies) against BMS-986515
All participants
Time frame: Up to 2 years
Number of participants who achieve definition of remission in systemic lupus erythematosus (DORIS) remission at Week 24
Systemic lupus erythematosus (SLE) participants
Time frame: Up to Week 24
Number of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 24
SLE participants
Time frame: Up to Week 24
Change in proteinuria measured by urine protein creatinine ratio (UPCR) from baseline to Week 24
SLE participants
Time frame: Up to Week 24
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline to Week 24
SLE, systemic sclerosis (SSc), and rheumatoid arthritis (RA) participants
Time frame: Up to Week 24
Number of participants who achieve Myositis Response Criteria Total Improvement Score (MRC TIS) at Week 24
Inflammatory myopathy (IIM) participants
Time frame: Up to Week 24
Change in International Myositis Outcome Assessment Collaborative Study Group (IMACS) outcome measure set for disease activity at week 24 from baseline
IIM participants
Time frame: Up to Week 24
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at week 24 from baseline
Dermatomyositis (DM) participants only
Time frame: Up to Week 24
Number of participants who achieve an minimal clinically important differences in SSc (MCID) from baseline of the modified Rodnan Skin Score (mRSS) at Week 24
SSc participants
Time frame: Up to Week 24
Change from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24
SSc participants
Time frame: Up to Week 24
Number of participants with low disease activity at Week 24 from baseline
RA participants
Time frame: Up to Week 24
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Not enrolling at this site — choose another above.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Sep 2025 (actual). Primary completion is estimated for Mar 2029, 42 months after the start.
Of 68 industry-sponsored phase 1 interventional studies under Autoimmune Diseases, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 32. This study's planned 42 months is above that.
Counting every sponsor, half of 94 studies reached it within 23 months; a quarter within 9 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Fludarabine · Cyclophosphamide · Tocilizumab
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company →