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Evaluating CC-97540 for Multiple Sclerosis and Myasthenia Gravis

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).

PHASE1 · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company · NCT06220201

This study is testing a new drug called CC-97540 to see if it can help people with different types of Multiple Sclerosis or hard-to-treat Myasthenia Gravis feel better and manage their symptoms.

Quick facts

PhasePHASE1
Study typeInterventional
Enrollment120 (estimated)
Ages18 Years to 60 Years
SexAll
SponsorJuno Therapeutics, Inc., a Bristol-Myers Squibb Company (industry)
Locations35 sites (Birmingham, Alabama and 34 other locations)
Trial IDNCT06220201 on ClinicalTrials.gov

What this trial studies

This study evaluates 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). Participants will be grouped based on their specific condition and severity, with eligibility criteria focusing on their Expanded Disability Status Scale (EDSS) scores and treatment history. The study involves administering CC-97540 along with Fludarabine and Cyclophosphamide to assess its effects on disease progression and symptoms.

Who should consider this trial

Good fit: Ideal candidates include individuals with relapsing or progressive forms of Multiple Sclerosis or refractory Myasthenia Gravis who meet specific EDSS criteria.

Not a fit: Patients with mild forms of Multiple Sclerosis or Myasthenia Gravis who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat forms of Multiple Sclerosis and Myasthenia Gravis.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific treatment is novel in its application.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS).

\- Myasthenia Gravis - Cohort 3

i)MGFA classification of II-IV at screening

ii) Documentation of autoantibodies against AChR or MuSK (historical or at Screening)

iii) Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics.

iv) Has had thymectomy, only if indicated according to current guidelines.

Exclusion Criteria

* Cohorts 1 and 2: Participants that cannot complete the 9-Hole Peg Test (9-HPT) in at least 1 hand in \<240 seconds unless extenuating medical conditions unrelated to MS prohibit this.
* Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in \< 150 seconds.
* Presence of other confounding peripheral nervous system disorders or other disorders that may impact muscle strength (eg, myositis) or cause weakness, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, Lambert-Eaton myasthenic syndrome.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Where this trial is running

Birmingham, Alabama and 34 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Multiple Sclerosis, Myasthenia Gravis, CC-97540, CAR T, CART, NEX T, NEXT, BMS-986353

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.