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Study of BMS-986353 for Systemic Sclerosis

This study is looking at how well and how safely a treatment called BMS-986353 (also known as Zolacabtagene-Autoleucel or Zola-cel), which is a type of CD19-CAR T cell therapy, works compared to standard care for people with active Systemic Sclerosis. Systemic Sclerosis is a chronic autoimmune disease that affects the skin and internal organs. You might be able to join if you are 16 years or older, have active Systemic Sclerosis based on specific criteria, and have certain positive antibody tests (Antinuclear Antibodies with nucleolar pattern and/or anti-Topoisomerase I antibodies). The main way researchers will know if the treatment is successful is by measuring changes in your lung function (Forced Vital Capacity, or FVC) after 12 months. The study status is currently unclear.

Study design
This interventional study plans to enroll 92 participants. Participants in one group may receive BMS-986353 if their condition worsens on standard care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 12 months, suggesting follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07335562

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

Not Yet Recruiting
PHASE3Ages 16+InterventionalTreatment
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
~92 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:BMS-986353FludarabineCyclophosphamideTocilizumabRituximabNintedanib

At a glance

Recruiting sites
0 of 56 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The absolute change from baseline in Forced Vital Capacity (FVC) in mL
Measured over At 12 months

Conditions

Systemic Sclerosis

Explore related trials

Systemic SclerodermaAntinuclear AntibodyScl-70 Antibody

Where it's being run

56 sites across 38 states
Germany7
France4
Japan3
Switzerland3
Colorado2
Pennsylvania2
Texas2
Spain2

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Participants must not have a requirement for supplemental oxygen therapy and/or Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) ≤ 40% (Hemoglobin (Hgb) corrected) at screening.
Participants must not have moderate to severe Pulmonary Arterial Hypertension (PAH) requiring PAH-specific combination treatment
Participants must not have pulmonary comorbidity including chronic obstructive pulmonary disease or asthma requiring daily oral corticosteroids, cigarette smoking (including e-cigarettes) within 3 months before screening or unwilling to avoid smoking throughout the study, and/or clinically significant abnormalities on HRCT not attributable to SSc assessed by the central reader at screening.
Participants must not have gastrointestinal (GI) dysmotility requiring Total Parenteral Nutrition (TPN).
Participants must not have current gangrene of a digit

What this trial measures

  • The absolute change from baseline in Forced Vital Capacity (FVC) in mLAt 12 months