Summary

Eligibility
for people ages 18-60 (full criteria)
Location
at UC Irvine
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

  • 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).

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
  • Local Institution - 0037 not yet accepting patients
    Portland Oregon 97239 United States
  • Swedish Medical Center accepting new patients
    Seattle Washington 98122 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