Evaluating a new treatment for severe scleroderma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 study aims to assess the efficacy, safety, and tolerability of rapcabtagene autoleucel in patients with severe refractory diffuse cutaneous systemic sclerosis (dcSSc) compared to rituximab. The study is designed as a randomized, open-label, multicenter trial that includes a lead-in cohort and a randomized cohort. Participants will receive either rapcabtagene autoleucel or rituximab, with the option for those on rituximab to switch to rapcabtagene autoleucel if their disease is not adequately controlled. Following treatment, participants will enter a long-term follow-up period to monitor outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.

Exclusion Criteria:

1. Any condition during Screening that could prevent a complete washout of medications as required per protocol or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study, as judged by the Investigator.
2. Participants with history of hypersensitivity to excipients in rapcabtagene autoleucel or to rituximab.
3. Any participant for whom treatment with rituximab is clinically inappropriate in the opinion of the investigator.
4. Any medical conditions that are not related to SSc that, in the opinion of the Investigator, would jeopardize the ability of the participant to tolerate lymphodepletion and anti-CD19 CAR-T cell therapy.
5. Rheumatic disease other than dcSSc, (except secondary Sjogren's syndrome or scleroderma myopathy),including limited cutaneous systemic sclerosis (lcSSc) or sine scleroderma at Screening.
6. Participants with pre-existing pulmonary hypertension.
7. Significant renal pathology at Screening.
8. Participants with uncontrolled stage II hypertension at Screening.
9. Vaccination with live attenuated vaccines within 6 weeks prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply.

Where it's running

• UCLA
  Los Angeles, California, United States Recruiting
• UCSF
  San Francisco, California, United States Recruiting
• UCSF
  San Francisco, California, United States Recruiting
• Sutter Health Network
  San Pablo, California, United States Recruiting
• FL Medical Clinic Orlando Health
  Zephyrhills, Florida, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting

+37 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.