NCT06868290

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA)

Detailed description

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.

Conditions

• ANCA Associated Vasculitis (AAV)

Interventions

Type	Name	Description
BIOLOGICAL	Rapcabtagene autoleucel	Single infusion of rapcabtagene autoleucel
OTHER	Active Comparator	Active comparator option as per protocol
DRUG	Glucocorticoids	Concomitant glucocorticoids as per protocol

Timeline

• Start date: 2025-03-13
• Primary completion: 2029-06-07
• Completion: 2030-05-24
• First posted: 2025-03-10
• Last updated: 2026-02-23

Locations

31 sites across 8 countries: United States, Brazil, Israel, Japan, Saudi Arabia, Singapore, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study