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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)

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524337-11-00
Enrollment
33
Registered
2026-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Sclerosis

Brief summary

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).

Detailed description

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.

Interventions

DRUGNINTEDANIB
DRUGFLUDARABINE PHOSPHATE
DRUGTOCILIZUMAB
DRUGCYCLOPHOSPHAMIDE
DRUGRITUXIMAB

Sponsors

Celgene Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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).

Secondary

MeasureTime frame
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.

Outcome results

None listed

Source: EU CTIS · Data processed: Jun 23, 2026