RecruitingPhase 2NCT07015983

A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)

A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE (Including Lupus Nephritis) With Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)

Sponsor

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

Enrollment

89 participants

Start Date

Jul 14, 2025

Study Type

INTERVENTIONAL

Conditions

Lupus Erythematosus, Systemic Lupus Nephritis

Summary

The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.

Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CC-97540, a drug called Cyclophosphamide, and others for people with lupus erythematosus, systemic and lupus nephritis. The study is currently recruiting participants at 95 locations. People eligible for this study include aged 16 Years and older.

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

Locations(96)

Local Institution - 0106

Phoenix, Arizona, United States

Local Institution - 0038

Los Angeles, California, United States

Local Institution - 0051

Los Angeles, California, United States

Local Institution - 0093

Newport Beach, California, United States

Lucile Packard Children's Hospital

Palo Alto, California, United States

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Local Institution - 0105

Denver, Colorado, 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 - 0073

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

USF Health

Tampa, Florida, United States

Florida Medical Clinic Orlando Health

Zephyrhills, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Local Institution - 0079

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Local Institution - 0108

Indianapolis, Indiana, United States

Local Institution - 0086

Baton Rouge, Louisiana, United States

Local Institution - 0110

Shreveport, Louisiana, United States

Local Institution - 0094

Boston, Massachusetts, United States

Local Institution - 0096

Ann Arbor, Michigan, United States

Local Institution - 0011

Rochester, Minnesota, United States

Atlantic Health System Overlook Medical Center

Summit, New Jersey, United States

Local Institution - 0101

Manhasset, New York, United States

Local Institution - 0082