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Scleroderma Phase II study evaluating rapcabtagene autoleucel in participants with diffuse cutaneous systemic sclerosis

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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

Sex: Any
Age: Adult (18 - 64)
Accepting Healthy People: No
Type: Interventional / Therapeutic
Trial Phase: Phase II
Conditions Being Studied:

Study Purpose

The purpose of this study is to evaluate if i.v. rapcabtagene autoleucel (administered once following lymphodepletion) is safe and effective in participants with severe refractory diffuse cutaneous systemic sclerosis.

Who Can Participate

Age: 18-65 years old

Principal Investigator
Marina Magrey MD

Department/Division
Medicine (Rheumatology)

UH IRB: SITE00002502
StudyID: 2025-01714
ClinicalTrials.gov: N/A

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