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.

NCT06868290

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

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Novartis Pharmaceuticals
~126 participants
Updated 2026-05-20 on ClinicalTrials.gov
What's tested:Rapcabtagene autoleucelActive ComparatorGlucocorticoids

At a glance

Recruiting sites
35 of 35 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Event-free survival (EFS)
Measured over From randomization until the occurrence of an EFS event, up to approx. 4 years after randomization
ANCA Associated Vasculitis (AAV)
35 sites across 23 states
Japan4
United Kingdom3
Minnesota2
Texas2
São Paulo2
Israel2
Tokyo2
Singapore2
  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

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  • 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.