臨床研究等提出・公開システム

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)

Study of BMS-986353, CD19-CAR T Cells, versus SoC in Participants with Active SSc (Breakfree-SSc) (CA061-1005)

Elain Karis

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

mg-jp-clinical_trial@bms.com

Elain Karis

Bristol-Myers Squibb

1-2-1 Otemachi, Chiyoda-ku, Tokyo

+81-120-093-507

MG-JP-RCO-JRCT@bms.com

Pending

July. 31, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- 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.

- 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.

Both

Systemic Sclerosis

[Arm A]
BMS-986353 (Specified dose on specified days)
Fludarabine (Specified dose on specified days)
Cyclophosphamide (Specified dose on specified days)
[Arm B]
Tocilizumab (Specified dose on specified days)
Rituximab (Specified dose on specified days)
Nintedanib (Specified dose on specified days)

The absolute change from baseline in Forced Vital Capacity (FVC) in mL (at 12 months)

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

+81-3-3822-2131

April. 24, 2026

Yes

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

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