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Clinical Trials in the EU / 2025-524337-11-00
Authorised, not yet recruiting Phase III

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)

2025-524337-11-00 · tracked via the Priya Life Science EU tracker
Sponsor
Celgene Corp
Sponsor type
Pharmaceutical company
Therapeutic area
Immune System Diseases
Decision date
19/06/2026
Enrollment target
37
Sites
Spain, Germany, France, Italy, Belgium

Condition studied

Systemic Sclerosis

Investigational medicinal product(s)

NINTEDANIBTOCILIZUMABCD19-Targeted NEX-T CAR TFLUDARABINE PHOSPHATECYCLOPHOSPHAMIDERITUXIMAB

Every trial of Nintedanib, Tocilizumab, Fludarabine and Rituximab across our registers →

Eligibility

Age group
18-64 years, 0-17 years, 65+ years
Sex
Female, Male

Primary endpoint

How much the amount of air a person can blow out of their lungs (called Forced Vital Capacity, or FVC) changes. This is measured in milliliters (mL).

Endpoint detail

How much the skin thickness (measured by the Modified Rodnan Skin Score, or mRSS) changes., Changes in lung function (FVC in mL) or in skin thickness (mRSS)., Changes in the percentage of predicted FVC (ppFVC), which compares a person’s lung function to what is expected for someone their age and size., Changes in how well the lungs transfer oxygen (called DLCO)., How long it takes for the disease to get worse, starting from when a person joins the study.

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-524337-11-00 on CTIS ↗ ← All trials in the EU