A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases

NCT07115745
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
125
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Lead sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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Start date
2025-09-04
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Number of sites
28
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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.
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Short title
A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
clinicaltrials.gov
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-08-16
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First posted
2025-08-11
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Registry last updated
2026-07-14
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Primary completion date
2029-03-15
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Start date
2025-09-04
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Participants
125
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Participant count basis
Estimated
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Planned participants
125
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Protocol amendments
2
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Number of sites
28
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07115745
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ClinicalTrials.gov ID
NCT07115745
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: Up to 24 months post BMS-986515 infusion

    All participants

  2. Number of participants with serious AEs (SAEs)

    Timeframe: Up to 24 months post BMS-986515 infusion

    All participants

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

    Timeframe: Up to 24 months post BMS-986515 infusion

    All participants

  4. Number of participants with laboratory abnormalities

    Timeframe: Up to 24 months post BMS-986515 infusion

    All participants

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

    Timeframe: Up to 24 months post BMS-986515 infusion

    All participants

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

    Timeframe: 28 days post-BMS-986515 infusion

    All participants

  1. Maximum observed concentration (Cmax)

    Timeframe: Up to 2 years

    All participants

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

    Timeframe: Up to 2 years

    All participants

  3. Time of maximum observed concentration (Tmax)

    Timeframe: Up to 2 years

    All participants

  4. Number of participants with interstitial lung disease (ILD) with no worsening of pulmonary function from baseline to Week 24

    Timeframe: Up to 2 years

    All participants

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

    Timeframe: Up to 2 years

    All participants

  6. Number of participants who achieve definition of remission in systemic lupus erythematosus (DORIS) remission at Week 24

    Timeframe: Up to Week 24

    Systemic lupus erythematosus (SLE) participants

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

    Timeframe: Up to Week 24

    SLE participants

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

    Timeframe: Up to Week 24

    SLE participants

  9. Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline to Week 24

    Timeframe: Up to Week 24

    SLE, systemic sclerosis (SSc), and rheumatoid arthritis (RA) participants

  10. Number of participants who achieve Myositis Response Criteria Total Improvement Score (MRC TIS) at Week 24

    Timeframe: Up to Week 24

    Inflammatory myopathy (IIM) participants

  11. Change in International Myositis Outcome Assessment Collaborative Study Group (IMACS) outcome measure set for disease activity at week 24 from baseline

    Timeframe: Up to Week 24

    IIM participants

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

    Timeframe: Up to Week 24

    Dermatomyositis (DM) participants only

  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

    Timeframe: Up to Week 24

    SSc participants

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

    Timeframe: Up to Week 24

    SSc participants

  15. Number of participants with low disease activity at Week 24 from baseline

    Timeframe: Up to Week 24

    RA participants

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

- 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.

- 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.

Sources for eligibility
clinicaltrials.gov

  • Brigham And Womens HospitalBoston, United StatesRecruiting
  • Duke UniversityDurham, United StatesRecruiting
  • Local Institution - 0007Camperdown, AustraliaWithdrawn
  • Local Institution - 0008Brisbane, AustraliaWithdrawn
  • Local Institution - 0013Clayton, AustraliaWithdrawn
  • Local Institution - 0040Salvador, BrazilNot yet recruiting
  • Local Institution - 0039Porto Alegre, BrazilNot yet recruiting
  • Local Institution - 0038São Paulo, BrazilNot yet recruiting
  • Local Institution - 0004Prague, CzechiaNot yet recruiting
  • Revmatologicky ustavPrague, CzechiaRecruiting
  • CHU Strasbourg-HautepierreStrasbourg, FranceRecruiting
  • Hopital Claude Huriez - CHU de LilleLille, FranceRecruiting
  • Universitaetsklinikum DuesseldorfDüsseldorf, GermanyRecruiting
  • Universitaetsklinikum Schleswig-Holstein Campus KielKiel, GermanyRecruiting
  • Charité - Universitaetsmedizin Berlin - Campus Bejnamin FranklinBerlin, GermanyRecruiting
  • Universitätsklinikum Carl Gustav Carus an der TU DresdenDresden, GermanyRecruiting
  • Local Institution - 0031Hamburg, GermanyWithdrawn
  • Sheba Medical CenterRamat Gan, IsraelRecruiting
  • Hadassah Medical CenterJerusalem, IsraelRecruiting
  • Uniwersyteckie Centrum KliniczneGdansk, PolandRecruiting
  • Szpital Specjalistyczny nr 1 w BytomiuBytom, PolandRecruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w GliwicachGliwice, PolandRecruiting
  • Local Institution - 0017Lodz, PolandWithdrawn
  • ARENSIA Exploratory MedicineCluj-Napoca, RomaniaRecruiting
  • Fundeni Clinical InstituteBucharest, RomaniaRecruiting

And 3 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1308-9273
  • 2024-517681-41
Sources for references
clinicaltrials.gov

Related records

Drugs (3)

Lead sponsors (1)

Conditions (12)

Targets (4)