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

Eligibility 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
• 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), limited cutaneous systemic sclerosis (lcSSc) or sine scleroderma at Screening.
• 6. Participants with pre-existing pulmonary hypertension.
• 7. Significant renal pathology at Screening, including:
• * Active SSc renal crisis
• * Confirmed diagnosis of glomerulonephritis
• 8. Participants with uncontrolled stage II hypertension at Screening.
• 9. Vaccination with live attenuated vaccines within 6 weeks prior to randomization.