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

NCT07115745 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: IM060-00012024-517681-41U1111-1308-9273
• Study Type: interventional
• Target: 125
• Locations: 10 countries
• Sites: 28

Brief 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.

Conditions

Refractory Autoimmune Diseases

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; CAR T; SLE; Lupus Nephritis; SSc; IIM; Polymyositis; Dermatomyositis; RA

Outcome Measures

Primary Outcomes (6)

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

  All participants

  Up to 24 months post BMS-986515 infusion

• Number of participants with serious AEs (SAEs)

  All participants

  Up to 24 months post BMS-986515 infusion

• Number of participants with AEs of special interest (AESIs)

  All participants

  Up to 24 months post BMS-986515 infusion

• Number of participants with laboratory abnormalities

  All participants

  Up to 24 months post BMS-986515 infusion

• Number of participants with Dose-Limiting Toxicities (DLTs)

  All participants

  Up to 24 months post BMS-986515 infusion

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

  All participants

  28 days post-BMS-986515 infusion

Secondary Outcomes (15)

• Maximum observed concentration (Cmax)

  Up to 2 years

• Area under the concentration-time curve (AUC)

  Up to 2 years

• Time of maximum observed concentration (Tmax)

  Up to 2 years

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

  Up to 2 years

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

  Up to 2 years

Study Arms (1)

BMS-986515 Administration

EXPERIMENTAL

Genetic: BMS-986515; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Tocilizumab

Interventions

BMS-986515 GENETIC

Specified dose on specified days

BMS-986515 Administration

Fludarabine DRUG

Specified dose on specified days

BMS-986515 Administration

Cyclophosphamide DRUG

Specified dose on specified days

BMS-986515 Administration

Tocilizumab DRUG

Specified dose on specified days

BMS-986515 Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Juno Therapeutics, Inc., a Bristol-Myers Squibb Company: lead

Study Sites (28)

Local Institution - 0041

Boston, Massachusetts, 02115, United States

NOT YET RECRUITING

Local Institution - 0037

Durham, North Carolina, 27705-2771, United States

NOT YET RECRUITING

Local Institution - 0007

Camperdown, New South Wales, 2050, Australia

NOT YET RECRUITING

Local Institution - 0008

Brisbane, Queensland, 4029, Australia

WITHDRAWN

Local Institution - 0013

Clayton, Victoria, 3168, Australia

NOT YET RECRUITING

Local Institution - 0040

Salvador, Estado de Bahia, 41253-190, Brazil

NOT YET RECRUITING

Local Institution - 0039

Porto Alegre, 0, Brazil

NOT YET RECRUITING

Local Institution - 0038

São Paulo, 01508-010, Brazil

NOT YET RECRUITING

Local Institution - 0004

Prague, Praha 5, 150 06, Czechia

NOT YET RECRUITING

Revmatologicky ustav

Prague, 12850, Czechia

RECRUITING

CHU Strasbourg-Hautepierre

Strasbourg, Alsace, 67098, France

RECRUITING

Hopital Claude Huriez - CHU de Lille

Lille, Nord, 59037, France

RECRUITING

Local Institution - 0023

Düsseldorf, North Rhine-Westphalia, 40225, Germany

NOT YET RECRUITING

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

Berlin, 10117, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, 01307, Germany

RECRUITING

Local Institution - 0031

Hamburg, 20246, Germany

NOT YET RECRUITING

Sheba Medical Center

Ramat Gan, Central District, 5262100, Israel

RECRUITING

Hadassah Medical Center

Jerusalem, 9112001, Israel

RECRUITING

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, 80-952, Poland

RECRUITING

Szpital Specjalistyczny nr 1 w Bytomiu

Bytom, Silesian Voivodeship, 41-902, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy w Gliwicach

Gliwice, Silesian Voivodeship, 44-100, Poland

RECRUITING

Local Institution - 0017

Lodz, Łódź Voivodeship, 93-513, Poland

NOT YET RECRUITING

ARENSIA Exploratory Medicine

Cluj-Napoca, Cluj, 400015, Romania

RECRUITING

Fundeni Clinical Institute

Bucharest, 022328, Romania

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña], 08041, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, 28034, Spain

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Autoimmune Diseases; Lupus Erythematosus, Systemic; Myositis; Scleroderma, Systemic; Arthritis, Rheumatoid; Musculoskeletal Diseases; Scleroderma, Diffuse; Sclerosis; Skin Diseases; Connective Tissue Diseases; Lupus Nephritis; Polymyositis; Dermatomyositis

Interventions

fludarabine; Cyclophosphamide; tocilizumab

Condition Hierarchy (Ancestors)

Immune System Diseases; Skin and Connective Tissue Diseases; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: August 11, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): March 15, 2029
• Study Completion (Estimated): August 16, 2030
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (2); BR (3); CZ (2); AU (3); IL (2); RO (2); ES (3); FR (2); PL (4); DE (5)