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

Prior treatment

• 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.
• Any participant for whom treatment with rituximab is clinically inappropriate in the opinion of the investigator.
• Vaccination with live attenuated vaccines within 6 weeks prior to randomization.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Other illness

• Participants with history of hypersensitivity to excipients in rapcabtagene autoleucel or to rituximab.
• 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.
• Participants with uncontrolled stage II hypertension at Screening.

Other

• Significant renal pathology at Screening.

• 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.