A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2) (NCT06220201)
A Phase 1, Multicenter, Single-arm, Dose-escalation Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants With Autoimmune Neurological Diseases: Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS), or Refractory Myasthenia Gravis (MG).
🩺 Plain-English Summary (8th-Grade Level)
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).
Who can join: Review the eligibility criteria below.
Location: Local Institution - 0011 — Birmingham, Alabama
Age range: 18 Years to 60 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (34 Sites)
Showing the first 25 of 34 sites.
- Local Institution - 0011 — Birmingham, Alabama
- University of California, Irvine — Irvine, California
- University of Colorado Anschutz Medical Campus — Aurora, Colorado
- Colorado Blood Cancer Institute — Denver, Colorado
- Yale-New Haven Hospital — North Haven, Connecticut
- University of Kansas Medical Center — Kansas City, Kansas
- Local Institution - 0005 — Boston, Massachusetts
- Washington University School of Medicine — St Louis, Missouri
- Hackensack University Medical Center — Hackensack, New Jersey
- Icahn School of Medicine at Mount Sinai — New York, New York
- Neurological Institute of New York — New York, New York
- University of Cincinnati Medical Center — Cincinnati, Ohio
- Cleveland Clinic Mellen Center — Cleveland, Ohio
- Oregon Health and Science University — Portland, Oregon
- Swedish Medical Center — Seattle, Washington
- Medical College of Wisconsin — Milwaukee, Wisconsin
- Antwerp University Hospital — Edegem, Antwerpen
- UZ Gent — Ghent, Oost-Vlaanderen
- Hopital Claude Huriez - CHU de Lille — Lille, Nord
- Pitie Salpetriere University Hospital — Paris, Ville de Paris
- Universitaetsklinikum Essen — Essen, North Rhine-Westphalia
- Universitaetsklinikum Magdeburg — Magdeburg, Saxony-Anhalt
- Local Institution - 0033 — Düsseldorf,
- Universitaetsklinikum Erlangen — Erlangen,
- Klinikum der Universität München Großhadern — München,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Multiple Sclerosis
- Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple Sclerosis — Birmingham, Alabama
- MSCopilot Users' Feedback in Real Life - Outcomes Regarding Integration in Patients' pathWay and Users' ExpeRience — New Orleans, Louisiana
- A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis — Phoenix, Arizona
- A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS) — Carlsbad, California
- The Synergistic Effects of AIH and FES in Persons With MS — Chicago, Illinois
- A Health Action Process Approach Online Intervention for People With Multiple Sclerosis — Champaign, Illinois
Explore by condition: All Multiple Sclerosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.