RECRUITING

A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

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Conditions

Systemic Lupus ErythematosusIdiopathic Inflammatory MyopathySystemic SclerosisCC-97540BMS-986353

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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 establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

Official Title

A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy or Systemic Sclerosis (Breakfree-1)

Quick Facts

Study Start:2023-09-13
Study Completion:2027-11-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05869955

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_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 Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
United States
Colorado Blood Cancer Institute
Denver, Colorado, 80218
United States
Local Institution - 0048
New Haven, Connecticut, 06520
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224
United States
University of Miami Hospital and Clinics, Sylvester Cancer Center
Miami, Florida, 33136
United States
Local Institution - 0053
Chicago, Illinois, 60607
United States
Local Institution - 0030
Baltimore, Maryland, 21287
United States
Local Institution - 0038
Boston, Massachusetts, 02115
United States
Local Institution - 0046
Boston, Massachusetts, 02115
United States
Local Institution - 0033
Worcester, Massachusetts, 01655
United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
United States
University of Michigan
Ann Arbor, Michigan, 48109-2800
United States
Local Institution - 0037
Detroit, Michigan, 48202
United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, 55905
United States
Local Institution - 0010
Saint Louis, Missouri, 63110
United States
University Of Nebraska Medical Center
Omaha, Nebraska, 68198
United States
Atlantic Health System Overlook Medical Center
Summit, New Jersey, 07901
United States
NYU Langone Health
New York, New York, 10016
United States
Local Institution - 0054
New York, New York, 10021
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Local Institution - 0055
New York, New York, 10065
United States
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Local Institution - 0027
Columbus, Ohio, 43203
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Local Institution - 0057
Seattle, Washington, 98105
United States
Local Institution - 0058
Seattle, Washington, 98109
United States
Swedish Medical Center
Seattle, Washington, 98122
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 Date2023-09-13
Study Completion Date2027-11-15

Study Record Updates

Study Start Date2023-09-13
Study Completion Date2027-11-15

Terms related to this study

Keywords Provided by Researchers

  • CC-97540
  • BMS-986353

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus
  • Idiopathic Inflammatory Myopathy
  • Systemic Sclerosis