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NCT06220201Phase 1RECRUITING

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)

Study 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 SclerosisMyasthenia Gravis
Interventions / Drugs
CC-97540FludarabineCyclophosphamide
View on ClinicalTrials.gov ↗
Sponsor
BMY
Bristol-Myers Squibb
Oncology
F27/100
Study Details
Enrollment120 participants
Primary Completion—
Lead SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company
Data Retrieved2026-04-11 04:08:14.746129+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 120 participants
Sponsor Catalyst Profile

Bristol-Myers Squibb (BMY) is the sponsoring company for this trial. BiotechSign currently grades this company F (27/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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