RecruitingPhase 2NCT06868290

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)


Sponsor

Novartis Pharmaceuticals

Enrollment

126 participants

Start Date

Mar 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Active Comparator, a drug called Glucocorticoids, and others for people with anca associated vasculitis (aav). The study is currently recruiting participants at 35 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRapcabtagene autoleucel

Single infusion of rapcabtagene autoleucel

OTHERActive Comparator

Active comparator option as per protocol

DRUGGlucocorticoids

Concomitant glucocorticoids as per protocol


Locations(35)

University Of Colorado

Aurora, Colorado, United States

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Northwestern University

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Michigan Med University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Oregon Health Sciences University

Portland, Oregon, United States

Baylor University Medical Center

Dallas, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

LDS Hospital

Salt Lake City, Utah, United States

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

Barretos, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Ramat Gan, Israel

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Kobe, Hyōgo, Japan

Novartis Investigative Site

Sendai, Miyagi, Japan

Novartis Investigative Site

Suita, Osaka, Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo, Japan

Novartis Investigative Site

Shinjuku-ku, Tokyo, Japan

Novartis Investigative Site

Chiba, Japan

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

London, United Kingdom

Novartis Investigative Site

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06868290


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