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Clinical Trials in the UK / NCT07015983
Active, not recruiting Phase 2

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)

NCT07015983 · tracked via the Priya Life Science UK tracker
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Phase
Phase 2
Started
2025-07-14
Last updated
2026-08-03

Condition(s) studied

Lupus Erythematosus, SystemicLupus Nephritis

Investigational drug(s) / intervention(s)

CC-97540FludarabineCyclophosphamide

CC-97540: Specified dose on specified days

Fludarabine: Specified dose on specified days

Cyclophosphamide: Specified dose on specified days

Study 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

Sex
ALL
Min age
16 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Participants must meet EULAR/ACR 2019 criteria for SLE. * Participants must have an inadequate response to appropriate doses of glucocorticoids and ≥ 2 immunosuppressant therapies, used for at least 3 months. * Participants must have active disease when signing ICF. Exclusion Criteria: * Participants must not have other diseases, conditions, or treatments that may confound interpretation of the effects of CC-97540 in SLE. * Uncontrolled or clinically significant cardiovascular conditions or CNS pathology participants must not have prior history of malignancies or lymphoproliferative disease, unless the participant has been free of the disease for ≥ 2 years, except for some non-invasive malignancies. * IOCBP who are pregnant, nursing, or breastfeeding, or who intend to become pregnant. * Participants must not have prior treatment with CAR T cell therapy, genetically modified T cell therapy, stem cell transplant or organ transplant. * Participants must not have received live vaccines within 6 weeks before LDC (lymphodepleting chemotherapy) administration. * Participant must not have inadequate organ function. * Other protocol-defined inclusion/exclusion criteria apply.

Primary outcome measure(s)

Trial sites (97)

FacilityCityRegionStatus
Local Institution - 0106 Phoenix Arizona
Local Institution - 0038 Los Angeles California
Local Institution - 0051 Los Angeles California
Local Institution - 0093 Newport Beach California
Lucile Packard Children's Hospital Palo Alto California
University of Colorado Anschutz Medical Campus Aurora Colorado
Colorado Blood Cancer Institute Denver Colorado
Mayo Clinic in Florida Jacksonville Florida
University of Miami Hospital and Clinics, Sylvester Cancer Center Miami Florida
Local Institution - 0073 Orlando Florida
Moffitt Cancer Center Tampa Florida
USF Health Tampa Florida
Florida Medical Clinic Orlando Health Zephyrhills Florida
Emory University School of Medicine Atlanta Georgia
Local Institution - 0079 Atlanta Georgia
Northside Hospital Atlanta Georgia
Local Institution - 0108 Indianapolis Indiana
Local Institution - 0086 Baton Rouge Louisiana
Local Institution - 0110 Shreveport Louisiana
Local Institution - 0094 Boston Massachusetts
Local Institution - 0096 Ann Arbor Michigan
Local Institution - 0011 Rochester Minnesota
Atlantic Health System Overlook Medical Center Summit New Jersey
Local Institution - 0101 Manhasset New York
Local Institution - 0082 New York New York
Hospital for Special Surgery New York New York
Icahn School of Medicine at Mount Sinai New York New York
Columbia University Irving Medical Center New York New York
Columbia University Pediatrics New York New York
Weill Cornell Medical College New York New York
Local Institution - 0111 Stony Brook New York
Carolinas HealthCare System SouthPark Charlotte North Carolina
Local Institution - 0135 Winston-Salem North Carolina
Cincinnati Children's Hospital Medical Center Cincinnati Ohio
Cleveland Clinic Cleveland Ohio
Local Institution - 0083 Philadelphia Pennsylvania
Baptist Memorial Hospital Memphis Tennessee
Baylor Scott and White Research Institute Dallas Texas
Local Institution - 0098 Dallas Texas
Local Institution - 0104 San Antonio Texas

+ 57 more sites — see the full list on the official registry below.

More Juno Therapeutics, Inc., a Bristol-Myers Squibb Company trials in the UK

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07015983 on ClinicalTrials.gov ↗ ← All trials in the UK