NCT06220201

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)

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).

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Multiple Sclerosis
• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	CC-97540	Specified dose on specified days
DRUG	Fludarabine	Specified dose on specified days
DRUG	Cyclophosphamide	Specified dose on specified days

Timeline

• Start date: 2024-03-28
• Primary completion: 2027-07-15
• Completion: 2027-07-15
• First posted: 2024-01-23
• Last updated: 2026-02-10

Locations

35 sites across 6 countries: United States, Belgium, France, Germany, Spain, United Kingdom

Regulatory

• FDA-regulated drug study