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

NCT ID NCT06868290

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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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

    Dallas, Texas, 75246, United States

  • Duke Clinical Research Institute

    Durham, North Carolina, 27710, United States

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • LDS Hospital

    Salt Lake City, Utah, 84143, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • Michigan Med University of Michigan

    Ann Arbor, Michigan, 48109-5271, United States

  • Northwestern University

    Chicago, Illinois, 60611, 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

    Chiba, Chiba, 2608677, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608648, Japan

  • Novartis Investigative Site

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    Sendai, Miyagi, 9808574, Japan

  • Novartis Investigative Site

    Suita, Osaka, 5650871, Japan

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 1138431, Japan

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 1608582, 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, Singapore, 308433, Singapore

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    Cambridge, CB2 0QQ, United Kingdom

  • Novartis Investigative Site

    Glasgow, G4 0SF, United Kingdom

  • Novartis Investigative Site

    London, W12 0HS, United Kingdom

  • Novartis Investigative Site

    Manchester, M13 9WL, United Kingdom

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Uni of Chi Medi Ctr Hema and Onco

    Chicago, Illinois, 60637, United States

  • University Of Colorado

    Aurora, Colorado, 80045, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

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