RecruitingPhase 1NCT07115745

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

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

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Enrollment

125 participants

Start Date

Sep 4, 2025

Study Type

INTERVENTIONAL

Conditions

Refractory Autoimmune Diseases

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing an experimental CAR T cell therapy — immune cells donated by healthy donors and engineered to target a protein called CD19 — in people with severe autoimmune diseases that have not responded to standard treatments. This includes lupus, inflammatory muscle disease, systemic sclerosis, and rheumatoid arthritis. **You may be eligible if...** - You have a confirmed diagnosis of one of the following: systemic lupus erythematosus (SLE), inflammatory myopathy (IIM), systemic sclerosis (SSc), or difficult-to-treat rheumatoid arthritis (RA) - Your disease is still active despite trying steroids and other immunosuppressive treatments - You meet specific disease activity criteria as assessed by your specialist **You may NOT be eligible if...** - Your disease is well-controlled or you have not yet tried standard treatments - You have conditions that would make CAR T cell therapy unsafe - You do not meet the detailed disease classification criteria for your condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICBMS-986515

Specified dose on specified days

DRUGFludarabine

Specified dose on specified days

DRUGCyclophosphamide

Specified dose on specified days

DRUGTocilizumab

Specified dose on specified days

Locations(28)

Local Institution - 0041

Boston, Massachusetts, United States

Local Institution - 0037

Durham, North Carolina, United States

Local Institution - 0007

Camperdown, New South Wales, Australia

Local Institution - 0008

Brisbane, Queensland, Australia

Local Institution - 0013

Clayton, Victoria, Australia

Local Institution - 0040

Salvador, Estado de Bahia, Brazil

Local Institution - 0039

Porto Alegre, Brazil

Local Institution - 0038

São Paulo, Brazil

Local Institution - 0004

Prague, Praha 5, Czechia

Revmatologicky ustav

Prague, Czechia

CHU Strasbourg-Hautepierre

Strasbourg, Alsace, France

Hopital Claude Huriez - CHU de Lille

Lille, Nord, France

Local Institution - 0023

Düsseldorf, North Rhine-Westphalia, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, Germany

Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin

Berlin, Germany

Universitätsklinikum Carl Gustav Carus an der TU Dresden

Dresden, Germany

Local Institution - 0031

Hamburg, Germany

Sheba Medical Center

Ramat Gan, Central District, Israel

Hadassah Medical Center

Jerusalem, Israel

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Szpital Specjalistyczny nr 1 w Bytomiu

Bytom, Silesian Voivodeship, Poland

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

Gliwice, Silesian Voivodeship, Poland

Local Institution - 0017

Lodz, Łódź Voivodeship, Poland

ARENSIA Exploratory Medicine

Cluj-Napoca, Cluj, Romania

Fundeni Clinical Institute

Bucharest, Romania

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [Barcelona], Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña], Spain

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, Spain

View Full Details on ClinicalTrials.gov

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NCT07115745