ClinicaliQ Trial Snapshot
- Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis — Recruiting • Phase II • Neurology • NCT06655896.
- What is being tested: Rapcabtagene autoleucel, a CAR-T cell therapy administered as a single infusion after lymphodepletion, compared against rituximab in patients with severe, treatment-resistant diffuse cutaneous systemic sclerosis (dcSSc).
- Patient eligibility overview: The trial enrolls participants with severe refractory diffuse cutaneous systemic sclerosis who have failed conventional therapies and meet specific disease severity criteria, representing a population with limited effective treatment options.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
The purpose of this study is to evaluate the efficacy, safety and tolerability of rapcabtagene autoleucel (administered once following lymphodepletion) in participants with severe refractory diffuse cutaneous systemic sclerosis relative to rituximab.
Eligibility Snapshot
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- Participant must fulfill the 2013 American College of Rheumatology/ European League Against Rheumatism classification criteria for systemic sclerosis and meet the diffuse cutaneous SSc (dcSSc) subset classification according to LeRoy. 2. Disease onset from the first non-Raynaud symptoms attributable to SSc (e.g., puffy hands, scleroderma, digital ulcers, arthralgia, dyspnea) within 7 years prior to the Screening visit. 3. Severe, progressive systemic sclerosis disease defined by at least one of the following: * Progressive systemic sclerosis-associated interstitial lung disease * Severe, progressive systemic sclerosis skin disease * Clinically significant systemic sclerosis-associated cardiac involvement at Screening 4. All recommended vaccinations received according to institutional, local or global guidelines for immuno-compromised patients.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.