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A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)
NCT05869955 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Tocilizumab
- DRUG CC-97540
Study Locations (20)
Massachusetts
- Local Institution - 0038 — Boston
- Local Institution - 0046 — Boston
- University of Massachusetts Chan Medical School — Worcester
- University of Massachusetts Chan Medical School — Worcester
New York
- NYU Langone Health — New York
- Local Institution - 0054 — New York
- Icahn School of Medicine at Mount Sinai — New York
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
- Colorado Blood Cancer Institute — Denver
Florida
- Mayo Clinic in Florida — Jacksonville
- University of Miami Hospital and Clinics, Sylvester Cancer Center — Miami
Michigan
- University of Michigan — Ann Arbor
- Henry Ford Medical Center - New Center One — Detroit
Connecticut
- Local Institution - 0048 — New Haven
Illinois
- Local Institution - 0053 — Chicago
Maryland
- Local Institution - 0030 — Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2023-09-13 |
| Est. Completion | 2028-08-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05869955
The ClinicalTrials.gov registry entry for NCT05869955 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 4 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05869955 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Massachusetts, New York, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05869955 about?
NCT05869955 is a clinical study titled "A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)". 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).
What is the current status of trial NCT05869955?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 270 participants. The study started on 2023-09-13. Estimated completion is 2028-08-29.
What conditions does trial NCT05869955 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Idiopathic Inflammatory Myopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05869955?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Tocilizumab (DRUG), CC-97540 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05869955?
This trial is sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05869955 being conducted?
This trial has 20 study locations across Colorado, Connecticut, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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