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

Description

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).

Conditions

Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis

Study Overview

Study Details

Study overview

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).

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 or Systemic Sclerosis (Breakfree-1)

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

Condition
Systemic Lupus Erythematosus
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

New Haven

Local Institution - 0048, New Haven, Connecticut, United States, 06520

Jacksonville

Mayo Clinic in Florida, Jacksonville, Florida, United States, 32224

Miami

University of Miami Hospital and Clinics, Sylvester Cancer Center, Miami, Florida, United States, 33136

Chicago

Local Institution - 0053, Chicago, Illinois, United States, 60607

Baltimore

Local Institution - 0030, Baltimore, Maryland, United States, 21287

Boston

Local Institution - 0038, Boston, Massachusetts, United States, 02115

Boston

Local Institution - 0046, Boston, Massachusetts, United States, 02115

Worcester

Local Institution - 0033, Worcester, Massachusetts, United States, 01655

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

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

    Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

    Study Record Dates

    2027-11-15