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Phase 2 Study for Diffuse Cutaneous Systemic Sclerosis

This study is looking at a treatment called rapcabtagene autoleucel for people with severe diffuse cutaneous systemic sclerosis (dcSSc), a serious form of scleroderma. It compares rapcabtagene autoleucel to another treatment, rituximab. Rapcabtagene autoleucel is a CAR-T therapy, which means it uses your own modified immune cells to fight the disease. The study aims to see how well rapcabtagene autoleucel works and if it's safe. You might be able to join if you are 18 to 70 years old and have dcSSc that meets specific criteria. The main goal is to see if participants show a significant improvement in their condition after 52 weeks. The study is currently recruiting about 96 participants.

Study design
This is a Phase 2, randomized, open-label study comparing rapcabtagene autoleucel to rituximab in about 96 participants. Some participants will receive rapcabtagene autoleucel, while others will receive rituximab.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants who receive rapcabtagene autoleucel will enter a long-term follow-up period after their infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06655896

Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Diffuse Cutaneous Systemic Sclerosis

Recruiting
PHASE2Ages 18–70InterventionalTreatment
Novartis Pharmaceuticals
~96 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:rapcabtagene autoleucelrituximab

At a glance

Recruiting sites
94 of 94 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Achievement of a treatment response as per the Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) definition at Week 52.
Measured over Week 52

Conditions

Scleroderma, Diffuse

Explore related trials

Systemic Scleroderma

Where it's being run

94 sites across 59 states
France8
Spain8
Germany5
California4
Austria3
São Paulo3
Israel3
Japan3

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Achievement of a treatment response as per the Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) definition at Week 52.Week 52

    To demonstrate the superiority of rapcabtagene autoleucel as a single infusion compared to rituximab, with respect to the proportion of participants achieving a Revised Composite Response Index in Systemic Sclerosis 50 (rCRISS50) response at Week 52. This response is assessed across 5 assessment domains: (1) modified Rodnan Skin Score (mRSS), (2) Health Assessment Questionnaire Disability Index (HAQ-DI), (3) patient global assessment (PGA), (4) physician global assessment (PhGA) and (5) percent-predicted forced vital capacity (FVC%).