RecruitingPhase 1NCT05869955

A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, or Rheumatoid Arthritis (Breakfree-1)

Sponsor

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

Enrollment

270 participants

Start Date

Sep 13, 2023

Study Type

INTERVENTIONAL

Conditions

Rheumatoid Arthritis Systemic Lupus Erythematosus Systemic Sclerosis Idiopathic Inflammatory Myopathy

Summary

The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of CAR-T cell therapy — where a patient's own immune cells are engineered to attack the immune system cells causing disease — in people with severe, treatment-resistant lupus (SLE). This is a cutting-edge approach that aims to essentially "reset" the immune system. **You may be eligible if...** - You have been diagnosed with systemic lupus erythematosus (SLE) using established classification criteria - You have specific lupus-related antibodies in your blood - Your lupus is currently active, affecting at least one major organ - Your lupus has not responded adequately to standard medications **You may NOT be eligible if...** - Your lupus is mild or well-controlled with current treatments - You have had recent serious infections or certain other medical conditions - You have certain organ damage that makes this treatment too risky 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

DRUGCC-97540

Specified dose on specified days

DRUGFludarabine

Specified dose on specified days

DRUGCyclophosphamide

Specified dose on specified days

DRUGTocilizumab

Specified dose on specified days

Locations(54)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Colorado Blood Cancer Institute

Denver, Colorado, United States

Local Institution - 0048

New Haven, Connecticut, United States

Mayo Clinic in Florida

Jacksonville, Florida, United States

University of Miami Hospital and Clinics, Sylvester Cancer Center

Miami, Florida, United States

Local Institution - 0053

Chicago, Illinois, United States

Local Institution - 0030

Baltimore, Maryland, United States

Local Institution - 0038

Boston, Massachusetts, United States

Local Institution - 0046

Boston, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

University of Massachusetts Chan Medical School

Worcester, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Medical Center - New Center One

Detroit, Michigan, United States

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Local Institution - 0028

Omaha, Nebraska, United States

Atlantic Health System Overlook Medical Center

Summit, New Jersey, United States

NYU Langone Health