RECRUITING

A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases

Talk to us

Conditions

Refractory Autoimmune DiseasesCAR-TCell TherapyAutoimmune diseaseSystemic lupus erythematosusidiopathic inflammatory myopathysystemic sclerosisrheumatoid arthritisMusculoskeletal DiseasesMyositisLupus Erythematosus, SystemicScleroderma, SystemicScleroderma, DiffuseAutoimmune DiseasesSclerosisSkin DiseasesConnective tissue diseasesBMS-986515Allogeneic CAR TCD19 Allogeneic CAR TAlloCAR T, Cell TherapyCAR TSLELupus NephritisSScIIMPolymyositisDermatomyositisRA

Quick Navigation

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 determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory autoimmune diseases.

Official Title

A Phase 1, Multicenter, Open-label Study of BMS-986515, Healthy Donor Allogeneic CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases

Quick Facts

Study Start:2025-09-04
Study Completion:2030-08-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07115745

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. * SLE population:.
  2. * IIM population:.
  3. * SSc population:.
  4. * RA population:.
  5. * Other protocol-defined inclusion/exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
8559073286
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)

Local Institution - 0041
Boston, Massachusetts, 02215
United States
Local Institution - 0037
Durham, North Carolina, 27705-2771
United States
Local Institution - 0033
Seattle, Washington, 98104
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 Date2025-09-04
Study Completion Date2030-08-16

Study Record Updates

Study Start Date2025-09-04
Study Completion Date2030-08-16

Terms related to this study

Keywords Provided by Researchers

  • CAR-T
  • Cell Therapy
  • Autoimmune disease
  • Systemic lupus erythematosus
  • idiopathic inflammatory myopathy
  • systemic sclerosis
  • rheumatoid arthritis
  • Musculoskeletal Diseases
  • Myositis
  • Lupus Erythematosus, Systemic
  • Scleroderma, Systemic
  • Scleroderma, Diffuse
  • Autoimmune Diseases
  • Sclerosis
  • Skin Diseases
  • Connective tissue diseases
  • BMS-986515
  • Allogeneic CAR T
  • CD19 Allogeneic CAR T
  • AlloCAR T, Cell Therapy
  • CAR T
  • SLE
  • Lupus Nephritis
  • SSc
  • IIM
  • Polymyositis
  • Dermatomyositis
  • RA

Additional Relevant MeSH Terms

  • Refractory Autoimmune Diseases