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Active, not recruiting Phase 2

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

NCT06868290 · tracked via the Priya Life Science UK tracker
Phase
Phase 2
Started
2025-03-13
Last updated
2026-09-04

Condition(s) studied

ANCA Associated Vasculitis (AAV)

Investigational drug(s) / intervention(s)

Rapcabtagene autoleucel →Active ComparatorGlucocorticoids

Rapcabtagene autoleucel: Single infusion of rapcabtagene autoleucel

Active Comparator: Active comparator option as per protocol

Glucocorticoids: Concomitant glucocorticoids as per protocol

Study 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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Key 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 Key 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

Primary outcome measure(s)

  • 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.

Trial sites (39)

FacilityCityRegionStatus
University Of Colorado Aurora Colorado
Mayo Clinic Jacksonville Jacksonville Florida
Northwestern University Chicago Illinois
Uni of Chi Medi Ctr Hema and Onco Chicago Illinois
Massachusetts General Hospital Boston Massachusetts
Michigan Med University of Michigan Ann Arbor Michigan
University of Minnesota Minneapolis Minnesota
Mayo Clinic Rochester Rochester Minnesota
Duke Clinical Research Institute Durham North Carolina
Oregon Health Sciences University Portland Oregon
University of Pennsylvania Philadelphia Pennsylvania
Baylor University Medical Center Dallas Texas
Houston Methodist Hospital Houston Texas
LDS Hospital Salt Lake City Utah
Novartis Investigative Site Salvador Estado de Bahia
Novartis Investigative Site Barretos São Paulo
Novartis Investigative Site São Paulo São Paulo
Novartis Investigative Site São Paulo Brazil
Novartis Investigative Site Haifa Israel
Novartis Investigative Site Ramat Gan Israel
Novartis Investigative Site Chiba Chiba
Novartis Investigative Site Sapporo Hokkaido
Novartis Investigative Site Kobe Hyōgo
Novartis Investigative Site Sendai Miyagi
Novartis Investigative Site Suita Osaka
Novartis Investigative Site Bunkyo Ku Tokyo
Novartis Investigative Site Shinjuku-ku Tokyo
Novartis Investigative Site Fukuoka Japan
Novartis Investigative Site Ishikawa Japan
Novartis Investigative Site Kyoto Japan
Novartis Investigative Site Riyadh Saudi Arabia
Novartis Investigative Site Singapore Singapore
Novartis Investigative Site Singapore Singapore
Novartis Investigative Site Basel Switzerland
Novartis Investigative Site Bern Switzerland
Novartis Investigative Site Cambridge United Kingdom
Novartis Investigative Site Glasgow United Kingdom
Novartis Investigative Site London United Kingdom
Novartis Investigative Site Manchester United Kingdom
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06868290 on ClinicalTrials.gov ↗ ← All trials in the UK