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

Recruiting now · Phase 2

Conditions studied: Scleroderma, Diffuse

In brief

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.

Key facts

Study ID

NCT06655896

Run by

Novartis Pharmaceuticals

People needed

96

Starts

2024-10-29

Expected to finish

2032-08-30

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• 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
• All recommended vaccinations received according to institutional, local or global guidelines for immuno-compromised patients.

You may not qualify if…

• 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.
• Participants with history of hypersensitivity to excipients in rapcabtagene autoleucel or to rituximab.
• Any participant for whom treatment with rituximab is clinically inappropriate in the opinion of the investigator.
• 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.
• Rheumatic disease other than dcSSc, (except secondary Sjogren's syndrome or scleroderma myopathy),including limited cutaneous systemic sclerosis (lcSSc) or sine scleroderma at Screening.
• Participants with pre-existing pulmonary hypertension.
• Significant renal pathology at Screening.
• Participants with uncontrolled stage II hypertension at Screening.
• Vaccination with live attenuated vaccines within 6 weeks prior to randomization.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• UCSF — San Francisco, California, United States (enrolling)
• UCSF — San Francisco, California, United States (enrolling)
• Sutter Health Network — San Pablo, California, United States (enrolling)
• FL Medical Clinic Orlando Health — Zephyrhills, Florida, United States (enrolling)
• Northwestern University — Chicago, Illinois, United States (enrolling)
• University Of Iowa — Iowa City, Iowa, United States (enrolling)
• Boston Medical Center — Boston, Massachusetts, United States (enrolling)
• Michigan Med University of Michigan — Ann Arbor, Michigan, United States (enrolling)
• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
• James Cancer Hospital — Columbus, Ohio, United States (enrolling)
• Oregon Health Sciences University — Portland, Oregon, United States (enrolling)
• Avera Cancer — Sioux Falls, South Dakota, United States (enrolling)
• LDS Hospital — Salt Lake City, Utah, United States (enrolling)
• Novartis Investigative Site — CABA, Argentina (enrolling)
• Novartis Investigative Site — Córdoba, Argentina (enrolling)
• Novartis Investigative Site — Camperdown, New South Wales, Australia (enrolling)
• Novartis Investigative Site — Darlinghurst, New South Wales, Australia (enrolling)
• Novartis Investigative Site — Graz, Austria (enrolling)
• Novartis Investigative Site — Vienna, Austria (enrolling)
• Novartis Investigative Site — Ghent, Belgium (enrolling)
• Novartis Investigative Site — Salvador, Estado de Bahia, Brazil (enrolling)
• Novartis Investigative Site — Curitiba, Paraná, Brazil (enrolling)
• Novartis Investigative Site — Barretos, São Paulo, Brazil (enrolling)
• Novartis Investigative Site — São Paulo, São Paulo, Brazil (enrolling)
• UCLA — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.