Trial intelligence / Profile preview

Rapcabtagene autoleucel versus rituximab in severe refractory diffuse cutaneous systemic sclerosis

2023-510380-34-00Phase 2Authorised

Sponsor
Novartis
Start
Dec 2024
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, CAR-T Cells → Engineered T Cells → Adoptive Cell Transfer → Cell Therapies, Vaccines & Immunotherapeutics
Countries
24
01

Overview

Phase 2, randomised, open-label trial in diffuse cutaneous systemic sclerosis (dcSSc) comparing Rapcabtagene autoleucel arm with Rituximab control arm (2 arms). Primary endpoint: Treatment response by rCRISS50 at Week 52. Planned start Dec 2024; status: authorised.

02

Drugs

rapcabtagene autoleucelrituximab
03

Conditions

diffuse cutaneous systemic sclerosis (dcSSc)

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