A Phase II, multi-part, five-year, randomized, open-label, assessor-blinded, active-controlled, multicenter study to evaluate the efficacy and safety of rapcabtagene autoleucel versus rituximab treatment in participants with severe refractory diffuse cutaneous systemic sclerosis

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510380-34-00

Acronym

CYTB323K12201

Enrollment

Registered

2024-10-02

Start date

2024-12-10

Completion date

Unknown

Last updated

2025-10-28

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

Conditions

Diffuse cutaneous systemic sclerosis (dcSSc)

Brief summary

Achievement of a treatment response as per the rCRISS50 definition at Week 52

Detailed description

Change from baseline in FVC% predicted at Week 52, Change from baseline in mRSS at Week 52, Change from baseline in HAQ-DI at Week 52, Safety evaluation includes adverse events, laboratory parameters, vital signs, ECGs, and mortality

Interventions

DRUGTOCILIZUMAB

DRUGRITUXIMAB

DRUGFLUDARABINE PHOSPHATE

DRUGCYCLOPHOSPHAMIDE

DRUGYTB323

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Achievement of a treatment response as per the rCRISS50 definition at Week 52	—

Secondary

Measure	Time frame
Change from baseline in FVC% predicted at Week 52, Change from baseline in mRSS at Week 52, Change from baseline in HAQ-DI at Week 52, Safety evaluation includes adverse events, laboratory parameters, vital signs, ECGs, and mortality	—

Countries

Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026