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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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

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

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

28 sites in 10 countries

Germany5 sites, 4 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

    Recruiting

  • Local Institution - 0031

    Hamburg, 20246

    Withdrawn

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, Schleswig-Holstein, 24105

    Catrin Meyer, Site 0021, 0431500227200

    Recruiting

Other trials in Germany

Poland4 sites, 3 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

    Recruiting

  • Local Institution - 0017

    Lodz, Łódź Voivodeship, 93-513

    Withdrawn

Other trials in Poland

Australia3 sites

  • Local Institution - 0008

    Brisbane, Queensland, 4029

    Withdrawn

  • Local Institution - 0007

    Camperdown, New South Wales, 2050

    Withdrawn

  • Local Institution - 0013

    Clayton, Victoria, 3168

    Withdrawn

Other trials in Australia

Brazil3 sites, 3 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

    Not yet recruiting

Other trials in Brazil

Spain3 sites, 3 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

    Recruiting

Other trials in Spain

United States2 sites, 2 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

    Recruiting

Other trials in United States

Czechia2 sites, 2 recruiting

  • Local Institution - 0004

    Prague, Praha 5, 150 06

    Site 0004

    Not yet recruiting

  • Revmatologicky ustav

    Prague, 12850

    Ladislav Senolt, Site 0001, 00420608721168

    Recruiting

Other trials in Czechia

France2 sites, 2 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

    Recruiting

Other trials in France

Israel2 sites, 2 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

    Recruiting

Other trials in Israel

Romania2 sites, 2 recruiting

  • Fundeni Clinical Institute

    Bucharest, 022328

    Mihai Abobului, Site 0018, 0040766412427

    Recruiting

  • ARENSIA Exploratory Medicine

    Cluj-Napoca, Cluj, 400015

    Ciprian Tomuleasa, Site 0003, 0741337480

    Recruiting

Other trials in Romania

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.

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 groups in NCT07115745
Study groupRoleWhat they receive
BMS-986515 AdministrationExperimentalNot 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.

  1. Number of participants with treatment-emergent adverse events (TEAEs)

    All participants

    Measured: Up to 24 months post BMS-986515 infusion

  2. Number of participants with serious AEs (SAEs)

    All participants

    Measured: Up to 24 months post BMS-986515 infusion

  3. Number of participants with AEs of special interest (AESIs)

    All participants

    Measured: Up to 24 months post BMS-986515 infusion

  4. Number of participants with laboratory abnormalities

    All participants

    Measured: Up to 24 months post BMS-986515 infusion

  5. Number of participants with Dose-Limiting Toxicities (DLTs)

    All participants

    Measured: Up to 24 months post BMS-986515 infusion

  6. Number of participants with DLTs that occur during the DLT evaluation period

    All participants

    Measured: 28 days post-BMS-986515 infusion

Secondary outcomes (15)

  1. Maximum observed concentration (Cmax)

    All participants

    Measured: Up to 2 years

  2. Area under the concentration-time curve (AUC)

    All participants

    Measured: Up to 2 years

  3. Time of maximum observed concentration (Tmax)

    All participants

    Measured: Up to 2 years

  4. 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

  5. Number of participants with a humoral immune response (anti-therapeutic antibodies) against BMS-986515

    All participants

    Measured: Up to 2 years

  6. 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

  7. Number of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 24

    SLE participants

    Measured: Up to Week 24

  8. Change in proteinuria measured by urine protein creatinine ratio (UPCR) from baseline to Week 24

    SLE participants

    Measured: Up to Week 24

  9. 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

  10. 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

  11. 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

  12. Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at week 24 from baseline

    Dermatomyositis (DM) participants only

    Measured: Up to Week 24

  13. 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

  14. Change from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24

    SSc participants

    Measured: Up to Week 24

  15. 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.

  1. First posted11 Aug 2025
  2. Study start4 Sep 2025
  3. Primary completion15 Mar 2029 (estimated)
  4. Study completion16 Aug 2030 (estimated)

Resources

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)
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

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