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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study ID
NCT07115745
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Refractory Autoimmune Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BMS-986515 — GENETIC
    Specified dose on specified days
  • Fludarabine — DRUG
    Specified dose on specified days
  • Cyclophosphamide — DRUG
    Specified dose on specified days
  • Tocilizumab — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Sep 4, 2025
Status verified
May 2026
Primary completion
Mar 15, 2029
Completion
Aug 16, 2030

Study Design

Enrollment
125 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BMS-986515 Administration

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 24 months post BMS-986515 infusion ]

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 (2)

FacilityCityStateZIPSite coordinators
Brigham And Womens HospitalBostonMassachusetts02115
Neda Shahriari, Site 0041
617-732-4918
Duke UniversityDurhamNorth Carolina27705-2771
Ankoor Shah, Site 0037
919-681-5698

Find similar trials in Boston, MA

By research site
Brigham And Womens Hospital· Boston, MADuke University· Durham, NC