Phase 2 Study for Severe Active GPA or MPA
This study is testing a treatment called rapcabtagene autoleucel for people with severe active Granulomatosis with Polyangiitis (GPA) or Microscopic Polyangiitis (MPA), which are types of ANCA-Associated Vasculitis (AAV). Rapcabtagene autoleucel is a type of CAR-T therapy, which uses your own modified immune cells. You might receive rapcabtagene autoleucel or a standard treatment. The study wants to see how well rapcabtagene autoleucel works and if it's safe, by measuring how long people live without certain events (Event-free survival). To join, you need to be between 18 and 75 years old, have a confirmed diagnosis of severe active GPA or MPA, and test positive for ANCA-autoantibodies. The study plans to enroll 126 participants.
- Study design
- This is a Phase 2, randomized study with an active control, meaning some participants will receive the study treatment and others will receive a standard treatment. It is assessor-blinded, so the people evaluating your health won't know which treatment you received.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants who receive rapcabtagene autoleucel will be followed for up to 15 years after their infusion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 2 Study Evaluating Rapcabtagene Autoleucel in Participants With Severe Active GPA or MPA
At a glance
Conditions
Where it's being run
35 sites across 23 statesStudy leadership
- Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals
Who to contact
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What this trial measures
- Event-free survival (EFS)From randomization until the occurrence of an EFS event, up to approx. 4 years after randomization
Event-free survival (EFS) defined as the time from Randomization to the first occurrence of as per protocol defined events.