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)
Active, not recruiting · Phase 2 · NCT07015983
Conditions: Lupus Erythematosus, Systemic, Lupus Nephritis
At a glance
- Research payments reported, 2025
- $936,412
- U.S. investigators named
- 14
- Sites paid
- 14
- Planned or actual enrollment
- 89
About the trial
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Tested
- CC-97540 (drug), Fludarabine (drug), Cyclophosphamide (drug)
- Dates
- Started 2025-07-14; completion 2032-06-15
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2026-08-03. Full record, eligibility and contacts (opens in a new tab)
Industry funding
E.r. Squibb & Sons, L.l.c. reported $936,412 in research payments for this study in 2025 (14 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Jessie L. Alexander, MD Pediatric Hematology & Oncology · Palo Alto, CA
- Melissa R. Griffith, M.D. Rheumatology · Aurora, CO
- Julio Gonzalez-paoli, MD Rheumatology · Tampa, FL
- Loutfi Succari, M.D. Rheumatology · Tampa, FL
- Eliezer M. Vanallen, M.D. Medical Oncology · Boston, MA
- Vikas Majithia, MD Rheumatology · Jackson, MS
- Neil Kramer, MD Rheumatology · Summit, NJ
- Caitlin Gribbin Hematology & Oncology · New York, NY
- Kyriakos A. Kirou, M.D. Specialist · New York, NY
- Margrit Wiesendanger, M.D., PH.D. Rheumatology · New York, NY
- Hermine I. Brunner, MD Pediatrics · Cincinnati, OH
- Emily A. Littlejohn, D.O. Internal Medicine · Cleveland, OH
- Ankit N. Mehta, M.D. Nephrology (Kidney) · Dallas, TX
- Philip J. Mease, MD Rheumatology · Seattle, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Seattle Children's Hospital, WA $900,000
- Atlantic Health Adolescent Medicine and Eating Disorders Program $20,491
- Mayo Clinic Jacksonville $4,026
- Usf $1,950
- Icahn School of Medicine at Mount Sinai Department of Microbiology PAlese Laboratory $1,846
- Florida Medical Clinic $1,389
- University of Colorado Anschutz Medical Campus $1,125
- Swedish Medical Center, WA $860
- Cleveland Clinic, OH $849
- Lucile PAckard Children's Research Hospital/stanford University $825
- Weill Cornell Medical College $804
- Hospital for Special Surgery, NY $754
- Baylor Scott and White Research Institute $753
- Cincinnati Children's Hospital Medical Center, OH $740
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.