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

NCT06868290 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-05-20

No results posted yet for this 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)

Conditions

  • ANCA Associated Vasculitis (AAV)

Interventions

BIOLOGICAL

Rapcabtagene autoleucel

Single infusion of rapcabtagene autoleucel

OTHER

Active Comparator

Active comparator option as per protocol

DRUG

Glucocorticoids

Concomitant glucocorticoids as per protocol

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-13
Primary Completion
2029-06-07
Completion
2030-05-24
FDA Drug
Yes

Countries

  • United States
  • Brazil
  • Israel
  • Japan
  • Saudi Arabia
  • Singapore
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06868290 on ClinicalTrials.gov