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

NCT07115745 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2026-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Refractory Autoimmune Diseases

Interventions

GENETIC

BMS-986515

Specified dose on specified days

DRUG

Fludarabine

Specified dose on specified days

DRUG

Cyclophosphamide

Specified dose on specified days

DRUG

Tocilizumab

Specified dose on specified days

Sponsors & Collaborators

  • Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-04
Primary Completion
2029-03-15
Completion
2030-08-16
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Czechia
  • France
  • Germany
  • Israel
  • Poland
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07115745 on ClinicalTrials.gov