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A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis

NCT07335562 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2026-05-15

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and safety of BMS-986353 versus standard of care in participants with active Systemic Sclerosis

Conditions

Interventions

DRUG

BMS-986353

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

DRUG

Rituximab

Specified dose on specified days

DRUG

Nintedanib

Specified dose on specified days

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

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

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-29
Primary Completion
2028-11-14
Completion
2030-11-11
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Japan
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT07335562 on ClinicalTrials.gov