BMS-986353 for Systemic Sclerosis

(Breakfree-SSc Trial)

Not yet recruiting at 15 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Must be taking: Immunomodulatory drugs

Must not be taking: Oral corticosteroids

Disqualifiers: Pulmonary hypertension, COPD, asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for people with active Systemic Sclerosis who meet specific criteria, including positive ANA or anti-Scl-70 antibodies, non-responsive to immunomodulatory drugs for ≥6 months, and confirmed ILD on HRCT. It's not suitable for those intolerant to the study medications.

Inclusion Criteria

My skin condition is getting worse.

I have not responded to or tolerated at least 6 months of immunotherapy.

I have arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BMS-986353 or standard of care treatment

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986353 (Zolacaptagene-Autoleucel / Zola-cel)

Trial Overview

The trial compares BMS-986353 (Zola-cel), a CD19-CAR T cell therapy, against standard treatments like Cyclophosphamide and Tocilizumab in treating Systemic Sclerosis. Participants will be randomly assigned to receive either Zola-cel or one of the standard care options.

How Is the Trial Designed?

Group I: Arm B: Standard of Care Experimental Treatment 3 Interventions

Group II: Arm A: BMS-986353 Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

19

Recruited

3,100+

Celgene Corporation

Industry Sponsor

Trials

446

Recruited

58,500+

Mark Alles

Celgene Corporation

Chief Executive Officer since 2016

Bachelor's degree from Lock Haven University of Pennsylvania

Sol J. Barer

Celgene Corporation

Chief Medical Officer since 2006

PhD in Organic and Physical Chemistry from Rutgers University