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

Last updated: May 19, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Dermatomyositis (Connective Tissue Disease)

Circulation Disorders

Lupus

Treatment

Active Comparator

Rapcabtagene autoleucel

Glucocorticoids

Clinical Study ID

NCT06868290
CYTB323I12201
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

Key inclusion criteria:

  1. Men and women, aged ≥18 and ≤ 75 years with a diagnosis of GPA or MPA according tothe 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

Exclusion

Key exclusion criteria:

  1. Any condition that could prevent a complete washout of medications or couldotherwise make the participant ineligible for anti-CD19 CAR-T therapy and furtherparticipation in the study

  2. Hypersensitivity and/or contraindications to any product to be given to theparticipant 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 theability of the participant to tolerate CD19 CAR-T cell therapy

  5. Inadequate organ function

Study Design

Total Participants: 126
Treatment Group(s): 3
Primary Treatment: Active Comparator
Phase: 2
Study Start date:
March 13, 2025
Estimated Completion Date:
May 24, 2030

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Salvador, Estado de Bahia 41253-190
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Salvador 3450554, Estado de Bahia 3471168 41253-190
    Brazil

    Site Not Available

  • Novartis Investigative Site

    Barretos, São Paulo 14784 400
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Barretos 3470451, São Paulo 3448433 14784 400
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo 3448439, São Paulo 3448433 01308-050
    Brazil

    Site Not Available

  • Novartis Investigative Site

    São Paulo, 01509-010
    Brazil

    Active - Recruiting

  • Novartis Investigative Site

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Haifa 294801, 3109601
    Israel

    Site Not Available

  • Novartis Investigative Site

    Ramat Gan, 5265601
    Israel

    Active - Recruiting

  • Novartis Investigative Site

    Ramat Gan 293788, 5265601
    Israel

    Site Not Available

  • Novartis Investigative Site

    Sapporo, Hokkaido 060-8648
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Sapporo city, Hokkaido 060 8648
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sapporo 2128295, Hokkaido 2130037 0608648
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kobe, Hyōgo 6500047
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kobe 1859171, Hyōgo 1862047 6500047
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kanazawa, Ishikawa 920 8641
    Japan

    Site Not Available

  • Novartis Investigative Site

    Kanazawa 1860243, Ishikawa-ken 1861387 920 8641
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sendai, Miyagi 9808574
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Sendai city, Miyagi 980 8574
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sendai 2111149, Miyagi 2111888 9808574
    Japan

    Site Not Available

  • Novartis Investigative Site

    Suita, Osaka 565-0871
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Suita 1851483, Osaka 1853904 5650871
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo 1138431
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo 1608582
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Chiba, 2608677
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Chiba 2113015, 260 8677
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuoka, 8128582
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Fukuoka 1863967, 8128582
    Japan

    Site Not Available

  • Novartis Investigative Site

    Ishikawa, 9208641
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kyoto, 6068507
    Japan

    Active - Recruiting

  • Novartis Investigative Site

    Kyoto 1857910, 6068507
    Japan

    Site Not Available

  • Novartis Investigative Site

    Riyadh, 11211
    Saudi Arabia

    Active - Recruiting

  • Novartis Investigative Site

    Riyadh 108410, 11211
    Saudi Arabia

    Site Not Available

  • Novartis Investigative Site

    Singapore, 119074
    Singapore

    Active - Recruiting

  • Novartis Investigative Site

    Singapore 1880252, S308433
    Singapore

    Site Not Available

  • Novartis Investigative Site

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Basel 2661604, 4031
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Bern 2661552, 3010
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    Cambridge 2653941, CB2 0QQ
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    London, W12 0HS
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    London 2643743, W12 0HS
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

  • University Of Colorado

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University Of Colorado

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Mayo Clinic Jacksonville

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville 4160021, Florida 4155751 32224
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Northwestern Memorial Hospital

    Evanston, Illinois 60611
    United States

    Site Not Available

  • Northwestern University

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • Michigan Med University of Michigan

    Ann Arbor, Michigan 48109 5271
    United States

    Active - Recruiting

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Clinic Rochester

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

  • Oregon Health Sciences University

    Portland, Oregon 97239
    United States

    Active - Recruiting

  • Oregon Health Sciences University

    Portland 5746545, Oregon 5744337 97239
    United States

    Site Not Available

  • Baylor University Medical Center

    Dallas, Texas 75246
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Houston Methodist Hospital

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • LDS Hospital

    Salt Lake City, Utah 84143
    United States

    Active - Recruiting

  • LDS Hospital

    Salt Lake City 5780993, Utah 5549030 84143
    United States

    Site Not Available

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