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NCT07015983 · ClinicalTrials.gov registry record · 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)
A Phase 2 study of Lupus Nephritis and Lupus Erythematosus, Systemic, sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 89
- Enrollment target
- 20
- Study locations
NCT07015983 is a Phase 2 study of Lupus Nephritis and Lupus Erythematosus, Systemic that is actively recruiting participants, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. The registered enrollment target is 89 participants, below the 307-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT07015983, a Phase 2 study of Lupus Nephritis and Lupus Erythematosus, Systemic, is actively recruiting participants, sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 89 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG CC-97540
Study Locations (20)
Florida
- Mayo Clinic in Florida - Jacksonville
- University of Miami Hospital and Clinics, Sylvester Cancer Center - Miami
- Local Institution - 0073 - Orlando
- Moffitt Cancer Center - Tampa
- USF Health - Tampa
- Florida Medical Clinic Orlando Health - Zephyrhills
California
- Local Institution - 0038 - Los Angeles
- Local Institution - 0051 - Los Angeles
- Local Institution - 0093 - Newport Beach
- Lucile Packard Children's Hospital - Palo Alto
Georgia
- Local Institution - 0076 - Athens
- Emory University School of Medicine - Atlanta
- Local Institution - 0079 - Atlanta
Arizona
- Local Institution - 0080 - Scottsdale
- Local Institution - 0106 - Scottsdale
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
- Local Institution - 0105 - Denver
Alabama
- Local Institution - 0009 - Birmingham
District of Columbia
- Local Institution - 0097 - Washington D.C.
Hawaii
- Local Institution - 0074 - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 89 participants |
| Start Date | 2025-07-14 |
| Est. Completion | 2032-06-15 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07015983
The ClinicalTrials.gov registry entry for NCT07015983 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 89 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 307-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (71% lower). The listed sponsor is Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Lupus Nephritis appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT07015983 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT07015983 about?
NCT07015983 is a clinical study titled "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)". 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.
What is the current status of trial NCT07015983?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 89 participants. The study started on 2025-07-14. Estimated completion is 2032-06-15.
What conditions does trial NCT07015983 study?
This clinical trial studies the following conditions: Lupus Nephritis, Lupus Erythematosus, Systemic.
What interventions are being tested in trial NCT07015983?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), CC-97540 (DRUG).
Who is sponsoring clinical trial NCT07015983?
This trial is sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07015983 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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