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NCT06868290PHASE2Recruiting

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

Novartis Pharmaceuticals

Start Date

3/13/2025

Completion Date

5/24/2030

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)

Detailed Description

This is a Phase 2, randomized, assessor-blinded active controlled study. This study comprises two cohorts: * A lead-in cohort enrolling participants to receive rapcabtagene autoleucel * A randomized cohort with participants receiving either rapcabtagene autoleucel or comparator. After end of study (EOS), participants who received rapcabtagene autoleucel infusion will enter a long-term follow-up (LTFU) period lasting up to 15 years after rapcabtagene autoleucel infusion. This LTFU will be described in a separate study protocol.

Eligibility Criteria

Age Range: 18 years to 75 years

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

Interventions

BIOLOGICAL

Rapcabtagene autoleucel

OTHER

Active Comparator

DRUG

Glucocorticoids

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Conditions

ANCA Associated Vasculitis (AAV)

Locations

University Of Colorado

Aurora, Colorado 80045

United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224

United States

Northwestern University

Chicago, Illinois 60611

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Michigan Med University of Michigan

Ann Arbor, Michigan 48109 5271

United States

University of Minnesota

Minneapolis, Minnesota 55455

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

Oregon Health Sciences University

Portland, Oregon 97239

United States

Baylor University Medical Center

Dallas, Texas 75246

United States

Houston Methodist Hospital

Houston, Texas 77030

United States

LDS Hospital

Salt Lake City, Utah 84143

United States

Novartis Investigative Site

Salvador, Estado de Bahia 41253-190

Brazil

Novartis Investigative Site

Barretos, São Paulo 14784 400

Brazil

Novartis Investigative Site

São Paulo, São Paulo 01308-050

Brazil

Novartis Investigative Site

São Paulo, 01509-010

Brazil

Novartis Investigative Site

Haifa, 3109601

Israel

Novartis Investigative Site

Ramat Gan, 5265601

Israel

Novartis Investigative Site

Sapporo, Hokkaido 060-8648

Japan

Novartis Investigative Site

Kobe, Hyōgo 6500047

Japan

Novartis Investigative Site

Sendai, Miyagi 9808574

Japan

Novartis Investigative Site

Suita, Osaka 565-0871

Japan

Novartis Investigative Site

Bunkyo Ku, Tokyo 1138431

Japan

Novartis Investigative Site

Shinjuku-ku, Tokyo 1608582

Japan

Novartis Investigative Site

Chiba, 2608677

Japan

Novartis Investigative Site

Fukuoka, 8128582

Japan

Novartis Investigative Site

Ishikawa, 9208641

Japan

Novartis Investigative Site

Kyoto, 6068507

Japan

Novartis Investigative Site

Riyadh, 11211

Saudi Arabia

Novartis Investigative Site

Singapore, 119074

Singapore

Novartis Investigative Site

Singapore, S308433

Singapore

Novartis Investigative Site

Basel, 4031

Switzerland

Novartis Investigative Site

Bern, 3010

Switzerland

Novartis Investigative Site

Cambridge, CB2 0QQ

United Kingdom

Novartis Investigative Site

London, W12 0HS

United Kingdom

Novartis Investigative Site

Manchester, M13 9WL

United Kingdom