Last updated 3 months ago

Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA

126 patients around the world
Available in United States, Brazil
This is a Phase 2, randomized, assessor-blinded active controlled study. This study comprises two cohorts: - A lead-in cohort enrolling participants to receive rapcabtagene autoleucel - A randomized cohort with participants receiving either rapcabtagene autoleucel or comparator. After end of study (EOS), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period lasting up to 15 years after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.
Novartis Pharmaceuticals
126Patients around the world

This study is for people with

Vasculitis
ANCA-associated vasculitis (AAV)
Granulomatosis with polyangiitis (GPA)
Microscopic polyangiitis (MPA)

Requirements for the patient

To 75 Years
All Gender

Medical requirements

Men and women, aged ≥18 and ≤ 75 years with a diagnosis of GPA or MPA according to the American College of Rheumatology/ European League Against Rheumatism 2022 classification criteria.
Positive test for ANCA-autoantibodies.
GPA and MPA participants with severe active disease.
Any condition that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study.
Hypersensitivity and/or contraindications to any product to be given to the participant as part of the study protocol.
Other systemic autoimmune diseases requiring therapy.
Any medical conditions that are not related to GPA/MPA that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy.
Inadequate organ function.
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