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

Inclusion Criteria:

1. Participant must fulfill the 2013 American College of Rheumatology/ European LeagueAgainst Rheumatism classification criteria for systemic sclerosis and meet thediffuse cutaneous SSc (dcSSc) subset classification according to LeRoy.

2. Disease onset from the first non-Raynaud symptoms attributable to SSc (e.g., puffyhands, scleroderma, digital ulcers, arthralgia, dyspnea) within 7 years prior to theScreening visit.

3. Severe, progressive systemic sclerosis disease defined by at least one of thefollowing:

• Progressive systemic sclerosis-associated interstitial lung disease

• Severe, progressive systemic sclerosis skin disease

• Clinically significant systemic sclerosis-associated cardiac involvement atScreening

4. All recommended vaccinations received according to institutional, local or globalguidelines for immuno-compromised patients.

Exclusion Criteria:

1. Any condition during Screening that could prevent a complete washout of medicationsas required per protocol or could otherwise make the participant ineligible foranti-CD19 CAR-T therapy and further participation in the study, as judged by theInvestigator.

2. Participants with history of hypersensitivity to excipients in rapcabtageneautoleucel or to rituximab.

3. Any participant for whom treatment with rituximab is clinically inappropriate in theopinion of the investigator.

4. Any medical conditions that are not related to SSc that, in the opinion of theInvestigator, would jeopardize the ability of the participant to toleratelymphodepletion and anti-CD19 CAR-T cell therapy.

5. Rheumatic disease other than dcSSc, (except secondary Sjogren's syndrome orscleroderma myopathy),including limited cutaneous systemic sclerosis (lcSSc) or sinescleroderma 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.