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) or Progressive Forms of Multiple Sclerosis (PMS).

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 Relapsing Forms of Multiple Sclerosis (RMS) or Progressive Forms of Multiple Sclerosis (PMS)

Keywords

Multiple Sclerosis, CC-97540, CAR T, CART, NEX T, NEXT, BMS-986353, RMS, PMS, RRMS, aSPMS, PPMS, iSPMS, 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).

You CAN'T join if...

  • Participants that cannot complete the 9-Hole Peg Test (9-HPT) for each hand in <240 seconds.
  • Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in < 150 seconds.
  • Participants must not have MS lesions or symptoms that may place patients at increased risk of neurotoxicity, including, but not limited to, tumefactive lesion (3 cm or greater within 5 years prior to Screening) or decreased level of consciousness, and/or presence of active, clinically significant concomitant central nervous system pathology other than MS that may confound the ability to interpret study results or complicate identification or evaluation of neurotoxicity.
  • 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 Multiple Sclerosis Research Study
Study Type
Interventional
Participants
Expecting 98 study participants
Last Updated