Refractory Autoimmune DiseasesPhase 1NCT07115745
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
A Phase 1 study testing BMS-986515, Fludarabine and Cyclophosphamide in people with Refractory Autoimmune Diseases, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 28 sites in 10 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Autoimmune Diseases
- What is being tested?
- BMS-986515, Fludarabine and Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 28 sitesin 10 countries
- Study dates
- 4 Sep 2025to 16 Aug 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemic lupus erythematosus (SLE) population:.
- Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR).
- 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.
- Inadequate response or intolerance to steroids and immunosuppressive therapies.
- Participants must have active disease at screening.
- Inflammatory myopathy (IIM) population:.
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- Participants meeting the 2017 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria.
- Participants must meet criteria for with severe, refractory IIM. iii) Participants who had inadequate response to steroids and prior immunosuppressive therapies.
- Evidence of active disease.
- Systemic sclerosis (SSc) population:.
- Participant must fulfill the 2013 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for systemic sclerosis.
- 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:.
- 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.
Who cannot join
- All participants:.
- 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.
- Previous CAR-T cell therapy. viii) Significant lung impairment. ix) Inadequate organ function. x) Active, clinically significant, central nervous system (CNS) disorders.
- SLE population:.
- Participants who have SLE because of drugs or have other autoimmune diseases along with SLE.
- IIM population:.
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- Participants who have other forms of myopathies other than IIM. ii) Severe muscle damage.
- SSc population:.
- People who have high blood pressure in the arteries of the lungs caused by SSc, which needs regular treatment to keep it under control.
- Rapidly deteriorating SSc, or history of severe kidney disease.
- RA population:.
- People who have additional autoimmune diseases along with RA.
- Other protocol-defined inclusion/exclusion criteria apply.
Trial locations and contacts
28 sites in 10 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
28 sites in 10 countries
Germany5 sites, 4 recruiting
- Recruiting
Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin
Berlin, 10117
David Simon, Site 0022, +49(0)9131-85-43253
- Recruiting
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 01307
Anne-Kathrin Tausche-Wunderlich, Site 0029, +493514584422
- Recruiting
Universitaetsklinikum Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Joerg Distler, Site 0023, 00492118117817
- Withdrawn
Local Institution - 0031
Hamburg, 20246
- Recruiting
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, 24105
Catrin Meyer, Site 0021, 0431500227200
Poland4 sites, 3 recruiting
- Recruiting
Szpital Specjalistyczny nr 1 w Bytomiu
Bytom, Silesian Voivodeship, 41-902
Aleksandra Zon-Giebel, Site 0020, 0048604752460
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-952
Anna Wojteczek, Site 0019, 0048692695133
- Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w Gliwicach
Gliwice, Silesian Voivodeship, 44-100
Sebastian Giebel, Site 0032, 48322788523
- Withdrawn
Local Institution - 0017
Lodz, Łódź Voivodeship, 93-513
Australia3 sites
- Withdrawn
Local Institution - 0008
Brisbane, Queensland, 4029
- Withdrawn
Local Institution - 0007
Camperdown, New South Wales, 2050
- Withdrawn
Local Institution - 0013
Clayton, Victoria, 3168
Brazil3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0039
Porto Alegre, 0
Site 0039
- Not yet recruiting
Local Institution - 0040
Salvador, Estado de Bahia, 41253-190
Site 0040
- Not yet recruiting
Local Institution - 0038
São Paulo, 01508-010
Site 0038
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035
Alfredo Guillen-Del-Castillo, Site 0011, 943746003
- Recruiting
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalunya [Cataluña], 08041
Ivan Castellvi Barranco, Site 0009, 34935565609
- Recruiting
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034
Maria Jesus Villanueva, Site 0010, 652662563
United States2 sites, 2 recruiting
- Recruiting
Brigham And Womens Hospital
Boston, Massachusetts, 02115
Neda Shahriari, Site 0041, 617-732-4918
- Recruiting
Duke University
Durham, North Carolina, 27705-2771
Ankoor Shah, Site 0037, 919-681-5698
Czechia2 sites, 2 recruiting
- Not yet recruiting
Local Institution - 0004
Prague, Praha 5, 150 06
Site 0004
- Recruiting
Revmatologicky ustav
Prague, 12850
Ladislav Senolt, Site 0001, 00420608721168
France2 sites, 2 recruiting
- Recruiting
Hopital Claude Huriez - CHU de Lille
Lille, Nord, 59037
Ibrahim YAKOUB-AGHA, Site 0006, +33320445551
- Recruiting
CHU Strasbourg-Hautepierre
Strasbourg, Alsace, 67098
Marc SCHERLINGER, Site 0005, 0388127954
Israel2 sites, 2 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem, 9112001
Dror Mevorach, Site 0016, 97226777317
- Recruiting
Sheba Medical Center
Ramat Gan, Central District, 5262100
Merav Lidar, Site 0015, 97235302156
Romania2 sites, 2 recruiting
- Recruiting
Fundeni Clinical Institute
Bucharest, 022328
Mihai Abobului, Site 0018, 0040766412427
- Recruiting
ARENSIA Exploratory Medicine
Cluj-Napoca, Cluj, 400015
Ciprian Tomuleasa, Site 0003, 0741337480
About this study
Official title: 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
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.
- Conditions
- Refractory Autoimmune Diseases
- Being tested
- BMS-986515, Fludarabine, Cyclophosphamide, Tocilizumab
- Keywords
- CAR-T, Cell Therapy, Autoimmune disease, Systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, rheumatoid arthritis, Musculoskeletal Diseases, Myositis, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Scleroderma, Diffuse, Autoimmune Diseases, Sclerosis, Skin Diseases, Connective tissue diseases, BMS-986515, Allogeneic CAR T, CD19 Allogeneic CAR T, AlloCAR T, Cell Therapy
- Medical subject headings
- Autoimmune Diseases, Lupus Erythematosus, Systemic, Myositis, Scleroderma, Systemic, Arthritis, Rheumatoid, Musculoskeletal Diseases, Scleroderma, Diffuse, Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986515Genetic
Specified dose on specified days
FludarabineDrug
Specified dose on specified days
CyclophosphamideDrug
Specified dose on specified days
TocilizumabDrug
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986515 Administration | Experimental | Not described Receives: Genetic: BMS-986515; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs)
All participants
Measured: Up to 24 months post BMS-986515 infusion
Number of participants with serious AEs (SAEs)
All participants
Measured: Up to 24 months post BMS-986515 infusion
Number of participants with AEs of special interest (AESIs)
All participants
Measured: Up to 24 months post BMS-986515 infusion
Number of participants with laboratory abnormalities
All participants
Measured: Up to 24 months post BMS-986515 infusion
Number of participants with Dose-Limiting Toxicities (DLTs)
All participants
Measured: Up to 24 months post BMS-986515 infusion
Number of participants with DLTs that occur during the DLT evaluation period
All participants
Measured: 28 days post-BMS-986515 infusion
Secondary outcomes (15)
Maximum observed concentration (Cmax)
All participants
Measured: Up to 2 years
Area under the concentration-time curve (AUC)
All participants
Measured: Up to 2 years
Time of maximum observed concentration (Tmax)
All participants
Measured: 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
Measured: Up to 2 years
Number of participants with a humoral immune response (anti-therapeutic antibodies) against BMS-986515
All participants
Measured: 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
Measured: Up to Week 24
Number of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 24
SLE participants
Measured: Up to Week 24
Change in proteinuria measured by urine protein creatinine ratio (UPCR) from baseline to Week 24
SLE participants
Measured: 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
Measured: Up to Week 24
Number of participants who achieve Myositis Response Criteria Total Improvement Score (MRC TIS) at Week 24
Inflammatory myopathy (IIM) participants
Measured: 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
Measured: Up to Week 24
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at week 24 from baseline
Dermatomyositis (DM) participants only
Measured: 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
Measured: Up to Week 24
Change from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24
SSc participants
Measured: Up to Week 24
Number of participants with low disease activity at Week 24 from baseline
RA participants
Measured: Up to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start4 Sep 2025
- Primary completion15 Mar 2029 (estimated)
- Study completion16 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115745
- Sponsor's protocol ID
- IM060-0001
- Other IDs
- 2024-517681-41, U1111-1308-9273
- Status last verified
- Jul 2026
- First submitted
- 7 Feb 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07115745
- Acronym / sponsor ID
- IM060-0001
- Conditions
- Refractory Autoimmune Diseases
- Keywords
- CAR-T, Cell Therapy, Autoimmune disease, Systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, rheumatoid arthritis, Musculoskeletal Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb CompanyIndustry (pharma, biotech, devices)
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 15 Mar 2029 (estimated)
- Study completion
- 16 Aug 2030 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BMS-986515 Administration | Experimental | Genetic: BMS-986515, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Tocilizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Systemic lupus erythematosus (SLE) population:.
- Diagnosis of SLE based on the 2019 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR).
- 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.
- Inadequate response or intolerance to steroids and immunosuppressive therapies.
- Participants must have active disease at screening.
Key exclusion criteria (13 listed)
- All participants:.
- 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.
- Previous CAR-T cell therapy. viii) Significant lung impairment. ix) Inadequate organ function. x) Active, clinically significant, central nervous system (CNS) disorders.
- SLE population:.
- IIM population:.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986515Specified dose on specified days | Genetic | BMS-986515 Administration |
| FludarabineSpecified dose on specified days | Drug | BMS-986515 Administration |
| CyclophosphamideSpecified dose on specified days | Drug | BMS-986515 Administration |
| TocilizumabSpecified dose on specified days | Drug | BMS-986515 Administration |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 24 months post BMS-986515 infusion
All participants
Number of participants with serious AEs (SAEs)
Time frame: Up to 24 months post BMS-986515 infusion
All participants
Number of participants with AEs of special interest (AESIs)
Time frame: Up to 24 months post BMS-986515 infusion
All participants
Number of participants with laboratory abnormalities
Time frame: Up to 24 months post BMS-986515 infusion
All participants
Number of participants with Dose-Limiting Toxicities (DLTs)
Time frame: Up to 24 months post BMS-986515 infusion
All participants
Number of participants with DLTs that occur during the DLT evaluation period
Time frame: 28 days post-BMS-986515 infusion
All participants
15 secondary outcomes
Maximum observed concentration (Cmax)
Time frame: Up to 2 years
Area under the concentration-time curve (AUC)
Time frame: Up to 2 years
Time of maximum observed concentration (Tmax)
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
Time frame: Up to 2 years
Number of participants with a humoral immune response (anti-therapeutic antibodies) against BMS-986515
Time frame: Up to 2 years
Number of participants who achieve definition of remission in systemic lupus erythematosus (DORIS) remission at Week 24
Time frame: Up to Week 24
Number of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 24
Time frame: Up to Week 24
Change in proteinuria measured by urine protein creatinine ratio (UPCR) from baseline to Week 24
Time frame: Up to Week 24
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline to Week 24
Time frame: Up to Week 24
Number of participants who achieve Myositis Response Criteria Total Improvement Score (MRC TIS) at Week 24
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
Time frame: Up to Week 24
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at week 24 from baseline
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
Time frame: Up to Week 24
Change from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24
Time frame: Up to Week 24
Number of participants with low disease activity at Week 24 from baseline
Time frame: Up to Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
Bristol-Myers Squibb study director
Bristol-Myers Squibb
28 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986515, Fludarabine and Cyclophosphamide in people with Refractory Autoimmune Diseases, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company at 28 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany, Poland, Australia, Brazil, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Up to 24 months post BMS-986515 infusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.