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Not yet recruiting 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

Phase III Interventional Systemic Sclerosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986353, Fludarabine, Cyclophosphamide, Tocilizumab.
Who it may be relevant to
Registry conditions: Systemic Sclerosis. Basic parameters: from 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Belgium, Canada, France, Germany +5
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis (Breakfree-SSc)

Overview

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

Detailed description

Participants in Arm B may receive BMS-986353 following confirmation of progression on standard of care.

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

Primary outcome measures

  • The absolute change from baseline in Forced Vital Capacity (FVC) in mL [Time frame: At 12 months]
Secondary outcome measures (12)
  • The absolute change from baseline in Modified Rodnan Skin Score (mRSS) [Time frame: At month 12]
  • The absolute change from baseline in Quantitative Interstitial Lung Disease-Whole Lung (QILD-WL) score [Time frame: Up to month 36]
  • Time to progression, defined as the time from randomization to progressive disease [Time frame: Approximately 54 months]
  • The change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-Fatigue [Time frame: Up to month 36]
  • The change from baseline in Scleroderma Clinical Index (ScleroID) [Time frame: Up to month 36]
  • The change from baseline in Scleroderma Health Assessment Questionnaire - Disability Index (SHAQ-DI) [Time frame: Up to month 36]
  • The change from baseline in PROMIS-29 [Time frame: Up to month 36]
  • The change from baseline in St. George's Respiratory Questionnaire (SGRQ) [Time frame: Up to month 36]
  • The change from baseline in EuroQol 5 Dimensions 5 Level (EQ-5D-5L) visual analog scale [Time frame: Up to month 36]
  • The change from baseline in EQ-5D-5L Utility Index [Time frame: Up to month 36]
  • The absolute change from baseline in FVC in mL [Time frame: Up to month 36]
  • The absolute change from baseline in FVC in mL/year [Time frame: Up to month 36]

Eligibility criteria

Inclusion criteria

\- Participants must fulfill the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for Systemic Sclerosis (SSc), and additionally have the following:.

i) Positive Antinuclear Antibodies (ANA) with nucleolar pattern and/or anti-Topoisomerase I (anti-Scl-70) antibodies.

ii) Confirmation of Interstitial Lung Disease (ILD) on centrally read High-Resolution Computed Tomography (HRCT) with ≥ 10% total lung involvement, with at least one of the following attributed to active SSc:.

A. Arthritis.

B. Myositis.

C. Carditis.

D. Progressive skin disease.

E. Elevated inflammatory markers.

\- Participants must have a non-response or intolerance despite ≥ 6 months of treatment with at least one immunomodulatory drug. Non-response is defined as a patient, who in the opinion of the investigator, is not adequately controlled/treated and requires treatment escalation.

Exclusion criteria

  • 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
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 17 centers
  • Local Institution - 0035 — Scottsdale
  • University of Colorado Anschutz Medical Campus — Aurora
  • Local Institution - 0001 — Denver
  • Local Institution - 0069 — Miami
  • Emory University School of Medicine — Atlanta
  • Local Institution - 0139 — Chicago
  • Local Institution - 0084 — Worcester
  • Local Institution - 0034 — Ann Arbor
  • … and 9 more centers
Germany · 7 centers
  • Local Institution - 0046 — Berlin
  • Local Institution - 0016 — Cologne
  • Local Institution - 0028 — Erlangen
  • Local Institution - 0042 — Leipzig
  • Local Institution - 0032 — München
  • Local Institution - 0033 — Tübingen
  • Local Institution - 0038 — Würzburg
Japan · 7 centers
  • Local Institution - 0026 — Sapporo
  • Local Institution - 0132 — Yokohama
  • Local Institution - 0137 — Suita
  • Local Institution - 0117 — Bunkyo-ku
  • Local Institution - 0123 — Fukuoka
  • Local Institution - 0136 — Maebashi
  • Local Institution - 0118 — Okayama
France · 6 centers
  • Local Institution - 0031 — Strasbourg
  • Local Institution - 0061 — Toulouse
  • Local Institution - 0049 — Bordeaux
  • Local Institution - 0012 — Bron
  • Local Institution - 0052 — Paris
  • Local Institution - 0141 — Rennes
Italy · 4 centers
  • Local Institution - 0103 — Rome
  • Local Institution - 0004 — Milan
  • Local Institution - 0108 — Pisa
  • Local Institution - 0106 — Milan
Spain · 4 centers
  • Local Institution - 0129 — A Coruña
  • Local Institution - 0138 — Barcelona
  • Local Institution - 0060 — Barcelona
  • Local Institution - 0009 — Málaga
United Kingdom · 4 centers
  • Local Institution - 0140 — London
  • Local Institution - 0063 — Leeds
  • Local Institution - 0059 — London
  • Local Institution - 0091 — Sheffield
Switzerland · 3 centers
  • Local Institution - 0047 — Basel
  • Local Institution - 0068 — Bern
  • Local Institution - 0078 — Zurich
Belgium · 2 centers
  • Local Institution - 0057 — Leuven
  • Local Institution - 0080 — Liège
Canada · 2 centers
  • Local Institution - 0104 — Halifax
  • Local Institution - 0088 — Sherbrooke

Identifiers

NCT: NCT07335562 · CA061-1005 · 2025-524337-11 · U1111-1330-3381

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗