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)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study ID
NCT06220201
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • CC-97540 — DRUG
    Specified dose on specified days
  • Fludarabine — DRUG
    Specified dose on specified days
  • Cyclophosphamide — DRUG
    Specified dose on specified days

Study Details

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).

Key Dates

Start date
Mar 28, 2024
Status verified
Feb 2026
Primary completion
Jul 15, 2027
Completion
Jul 15, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Administration of CC-97540 (RMS arm)
  • Experimental: Administration of CC-97540 (PMS arm)
  • Experimental: Administration of CC-97540 (MG arm)

Primary Outcome Measure

Number of participants with adverse events (AEs) [ Time Frame: Up to week 104 ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain NCT # and Site #.

Locations (17)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Khurram Bashir, Site 0011
000-000-0000
University of California, IrvineIrvineCalifornia92697
Michael Sy, Site 0028
949-824-3990
University of Colorado Anschutz Medical CampusAuroraColorado80045
Amanda Piquet, Site 0023
303-724-2194
Colorado Blood Cancer InstituteDenverColorado80218
Richard Nash, Site 0035
303-981-2305
Yale-New Haven HospitalNew HavenConnecticut06510
Erin Longbrake, Site 0032
203-287-6100
University of Kansas Medical CenterKansas CityKansas66160
Sharon Lynch, Site 0003
913-588-6980
Local Institution - 0039New OrleansLouisiana70121-
Local Institution - 0005BostonMassachusetts02114-
Washington University School of MedicineSt LouisMissouri63110
Robert Naismith, Site 0004
314-362-3293
Hackensack University Medical CenterHackensackNew Jersey07601
Krupa Pandey, Site 0029
551-996-8100
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Fred Lublin, Site 0042
212-241-6854
Neurological Institute of New YorkNew YorkNew York10032
Rebecca Farber, Site 0009
212-305-6876
University of Cincinnati Medical CenterCincinnatiOhio45219
Aram Zabeti, Site 0038
513-558-0269
Cleveland Clinic Mellen CenterClevelandOhio44195
Jeffrey Cohen, Site 0001
216-445-9855
Oregon Health and Science UniversityPortlandOregon97239
Vijayshree Yadav, Site 0037
503-494-5759
Swedish Medical CenterSeattleWashington98122
Pavle Repovic, Site 0007
206-320-2200
Medical College of WisconsinMilwaukeeWisconsin53226
Ahmed Obeidat, Site 0002
414-955-0619

Find similar trials in Birmingham, AL

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University of Alabama at Birmingham· Birmingham, ALUniversity of California, Irvine· Irvine, CAUniversity of Colorado Anschutz Medical Campus· Aurora, COColorado Blood Cancer Institute· Denver, COYale-New Haven Hospital· New Haven, CTUniversity of Kansas Medical Center· Kansas City, KS

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