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?

This trial tests the effectiveness of the new treatment BMS-986353 (Zolacaptagene-Autoleucel / Zola-cel) compared to the usual treatment for individuals with active Systemic Sclerosis, a condition where the immune system attacks the body, often affecting the skin and lungs. The study includes two groups: one receiving BMS-986353 and the other receiving standard care. Participants must have Systemic Sclerosis with lung involvement and symptoms like joint pain or skin issues, and they must still need more help despite taking medication for six months. This trial excludes those needing extra oxygen or those with severe lung or heart issues unrelated to Systemic Sclerosis. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop your current medications. However, it mentions that participants must have been on an immunomodulatory drug for at least 6 months without adequate response, so you might need to continue those medications.

Is there any evidence suggesting that BMS-986353 is likely to be safe for humans?

Research has shown that BMS-986353, a treatment under study for Systemic Sclerosis, has a good safety record. Earlier studies found that patients generally tolerated this treatment well. Specifically, data from initial research with a small group of patients indicated that BMS-986353 was safe and helped improve conditions like skin thickening and lung function. Although some side effects occurred, they were mostly mild or moderate. This suggests that BMS-986353 could be a safe option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Systemic Sclerosis?

Most treatments for systemic sclerosis focus on managing symptoms and slowing disease progression, often using immunosuppressants and anti-fibrotic agents. But BMS-986353, also known as Zolacaptagene-Autoleucel or Zola-cel, works differently. It targets the underlying mechanisms of the disease by potentially modulating the immune response more precisely. Researchers are excited because this approach could offer more effective control over the disease, potentially reducing symptoms and improving quality of life more significantly than current options. This innovative targeting method sets it apart from existing treatments.

What evidence suggests that BMS-986353 could be an effective treatment for Systemic Sclerosis?

Research has shown that BMS-986353, which participants in this trial may receive, may help treat systemic sclerosis. In an earlier study, 64% of patients experienced significant improvement, while 27% had moderate benefits. The treatment targets CD19, a key protein on immune cells, potentially reducing disease activity. Early results also indicate that the treatment is generally safe and well-tolerated by patients. These findings suggest that BMS-986353 could be a helpful treatment option for people with systemic sclerosis. ^{1 2 3 4 5}

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07335562

NCT07335562 | A Study to Compare the Efficacy and ...

A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, ...

2.

news.bms.com

news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Encouraging-Data-from-Phase-1-Breakfree-1-Study-of-CD19-NEX-T-CAR-T-Cell-Therapy-in-Three-Chronic-Autoimmune-Diseases-at-ACR-Convergence-2025/default.aspx

Corporate news details

Promising initial results showed that of the efficacy-evaluable patients, 64% of patients achieved a major response, and 27% achieved a moderate ...

3.

acrabstracts.org

acrabstracts.org/abstract/efficacy-and-safety-of-bms-986353-a-cd19-directed-chimeric-antigen-receptor-t-cell-therapy-manufactured-using-a-next-generation-process-updated-data-from-a-phase-1-trial-in-patients-with-systemic-sc/

Efficacy and Safety of BMS-986353, a CD19-Directed ...

Early data from Breakfree-1 trial (NCT05869955) in severe, refractory autoimmune diseases (ADs) showed promising efficacy and manageable safety with BMS- ...

4.

medcommsvdp.web.bms.com

medcommsvdp.web.bms.com/f5f8ca35-de1c-4635-8ba4-c127a1709f00/6d003fa0-b4c0-416f-bb55-ddf4c86940bd/6d003fa0-b4c0-416f-bb55-ddf4c86940bd_source__v.pdf

Tolerability and efficacy of BMS-986353 (CC-97540), a ...

• Here, we report updated data on the tolerability and efficacy of ... manufactured using a next-generation process for systemic sclerosis: updated data from the ...

5.

ard.eular.org

ard.eular.org/article/S0003-4967(25)02069-2/abstract

POS0656 TOLERABILITY AND EFFICACY OF BMS-986353 ...

Patients with SSc who received DL1 showed complete B-cell depletion and overall consistent, robust transgene expansion compared with patients with diffuse large ...