Summary

Eligibility
for people ages 18-60 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
completion around

Description

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).

Official Title

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).

Keywords

Multiple Sclerosis, Myasthenia Gravis, CC-97540, CAR T, CART, NEX T, NEXT, BMS-986353, RMS, PMS, RRMS, aSPMS, PPMS, iSPMS, MG, gMG, refractory myasthenia gravis, general myasthenia gravis, CD19, Muscle Weakness, Sclerosis, Cyclophosphamide, Fludarabine

Eligibility

You can join if…

Open to people ages 18-60

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

You CAN'T join if...

  • 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.

Locations

  • University of California, Irvine accepting new patients
    Irvine California 92697 United States
  • Colorado Blood Cancer Institute accepting new patients
    Denver Colorado 80218 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT06220201
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated