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Could a One-Time immune cell treatment tame severe vasculitis?

NCT ID NCT06868290

Recruiting now Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests a one-time infusion of rapcabtagene autoleucel, a CAR-T cell therapy made from a patient's own immune cells, against standard treatments for severe active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). About 126 adults aged 18-75 with confirmed ANCA-positive vasculitis will be enrolled. The goal is to see if this cell therapy can control the disease better than usual care and reduce the need for steroids.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
rapcabtagene autoleucel (a CAR-T cell therapy made from the patient's own immune cells)
What this could lead to
If it works, this could offer a new way to control severe vasculitis without long-term heavy medications, potentially reducing flares and steroid dependence.
What could go wrong
This is an early Phase 2 trial with only 126 participants, so results may not apply to everyone. CAR-T therapies can cause serious side effects like cytokine release syndrome or infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

anti-neutrophil cytoplasmic antibody-associated vasculitis granulomatosis with polyangiitis microscopic polyangiitis vasculitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ANCA ASSOCIATED VASCULITIS (AAV)

Contacts and locations

Locations

  • Baylor University Medical Center

    RECRUITING

    Dallas, Texas, 75246, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • LDS Hospital

    RECRUITING

    Salt Lake City, Utah, 84143, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Michigan Med University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109 5271, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Novartis Investigative Site

    RECRUITING

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Novartis Investigative Site

    RECRUITING

    Barretos, São Paulo, 14784 400, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, São Paulo, 01308-050, Brazil

  • Novartis Investigative Site

    RECRUITING

    São Paulo, 01509-010, Brazil

  • Novartis Investigative Site

    RECRUITING

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    RECRUITING

    Sapporo, Hokkaido, 060-8648, Japan

  • Novartis Investigative Site

    RECRUITING

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    RECRUITING

    Sendai, Miyagi, 9808574, Japan

  • Novartis Investigative Site

    RECRUITING

    Suita, Osaka, 565-0871, Japan

  • Novartis Investigative Site

    RECRUITING

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    RECRUITING

    Shinjuku-ku, Tokyo, 1608582, Japan

  • Novartis Investigative Site

    RECRUITING

    Chiba, 2608677, Japan

  • Novartis Investigative Site

    RECRUITING

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    RECRUITING

    Ishikawa, 9208641, Japan

  • Novartis Investigative Site

    RECRUITING

    Kyoto, 6068507, Japan

  • Novartis Investigative Site

    RECRUITING

    Riyadh, 11211, Saudi Arabia

  • Novartis Investigative Site

    RECRUITING

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    RECRUITING

    Singapore, S308433, Singapore

  • Novartis Investigative Site

    RECRUITING

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, W12 0HS, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Oregon Health Sciences University

    RECRUITING

    Portland, Oregon, 97239, United States

  • University Of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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