A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
Active, not recruiting · Phase 1 · NCT05869955
Conditions: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, Rheumatoid Arthritis
At a glance
- Research payments reported, 2025
- $92,550
- U.S. investigators named
- 7
- Sites paid
- 7
- Planned or actual enrollment
- 270
About the trial
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company (with Bristol-Myers Squibb Services Unlimited Company)
- Tested
- CC-97540 (drug), Fludarabine (drug), Cyclophosphamide (drug), Tocilizumab (drug)
- Dates
- Started 2023-09-13; completion 2028-08-29
- Results posted
- Not yet
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).
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 $92,550 in research payments for this study in 2025 (7 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
- Lazaros J. Lekakis, MD Hematology & Oncology · Miami, FL
- Damiano Rondelli, M.D. Hematology & Oncology · Chicago, IL
- Alireza Meysami, M.D. Rheumatology · Novi, MI
- Saira Z. Sheikh, M.D. Internal Medicine · Chapel Hill, NC
- Margrit Wiesendanger, M.D., PH.D. Rheumatology · New York, NY
- Chitra Hosing, M.D. Hematology & Oncology · Houston, TX
- Heidi Jacobe, M.D. Dermatology · Dallas, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Ut Southwestern Medical Center $23,528
- Ut MD Anderson Cancer Center $19,952
- Icahn School of Medicine at Mount Sinai, Mount Sinai Medical Center $19,952
- Henry Ford Medical Center New Center One $12,034
- University of Miami Hospital $8,091
- University of Illinois Hospital and Clinics, IL $7,319
- Unc Hospitals, NC $1,675
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.