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).
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Summary
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).
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria \- Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1. i) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5. ii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed/refractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months. \- Progressive forms of MS - Cohort 2. i) Participants must have an EDSS ≥ 3.0 and ≤ 6.0. ii) Participants must have a diagnosi…
Interventions
- DrugCC-97540
Specified dose on specified days
- DrugFludarabine
Specified dose on specified days
- DrugCyclophosphamide
Specified dose on specified days
Locations (35)
- University of Alabama at BirminghamBirmingham, Alabama
- University of California, IrvineIrvine, California
- University of Colorado Anschutz Medical CampusAurora, Colorado
- Colorado Blood Cancer InstituteDenver, Colorado
- Yale-New Haven HospitalNew Haven, Connecticut
- University of Kansas Medical CenterKansas City, Kansas