A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA) (CYTB323I12201)

Recruiting

• Conditions: Granulomatosis with Polyangiitis (GPA), Microscopic Polyangiitis (MPA)

• Registration Number: jRCT2013240076
• Lead Sponsor: Novartis Pharma. K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-11
• Study Start: 2025-03-13
• Last Update Posted: 2025-06-06

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

1. 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 (ACR/EULAR 2022) classification criteria
2. Positive test for ANCA-autoantibodies
3. GPA and MPA participants with severe active disease

Exclusion Criteria

1. 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
2. Hypersensitivity and/or contraindications to any product to be given to the participant as part of the study protocol
3. Other systemic autoimmune diseases requiring therapy
4. 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
5. Inadequate organ function

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Event-free survival