RECRUITING

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)

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Conditions

Multiple SclerosisMyasthenia GravisCC-97540CAR TCARTNEX TNEXTBMS-986353RMSPMSRRMSaSPMSPPMSiSPMSMGgMGrefractory myasthenia gravisgeneral myasthenia gravisCD19

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Quick Facts

Study Start:2024-03-28
Study Completion:2027-07-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06220201

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
855-907-3286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294
United States
University of California, Irvine
Irvine, California, 92697
United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Local Institution - 0032
New Haven, Connecticut, 06510
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
Local Institution - 0039
New Orleans, Louisiana, 70121
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Local Institution - 0042
New York, New York, 10029
United States
Neurological Institute of New York
New York, New York, 10032
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Local Institution - 0037
Portland, Oregon, 97239
United States
Local Institution - 0021
Philadelphia, Pennsylvania, 19104
United States
Local Institution - 0006
Dallas, Texas, 75390
United States
Swedish Medical Center
Seattle, Washington, 98122
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-28
Study Completion Date2027-07-15

Study Record Updates

Study Start Date2024-03-28
Study Completion Date2027-07-15

Terms related to this study

Keywords Provided by Researchers

  • CC-97540
  • CAR T
  • CART
  • NEX T
  • NEXT
  • BMS-986353
  • RMS
  • PMS
  • Multiple sclerosis
  • RRMS
  • aSPMS
  • PPMS
  • iSPMS
  • MG
  • gMG
  • refractory myasthenia gravis
  • general myasthenia gravis
  • CD19

Additional Relevant MeSH Terms

  • Multiple Sclerosis
  • Myasthenia Gravis