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Could CAR t-cells tame myasthenia gravis? early trial launches

NCT ID NCT06626919

Disease control Sponsor: Arcellx, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-phase study tests a new treatment called anitocabtagene autoleucel (anito-cel) for people with generalized myasthenia gravis, a condition that causes muscle weakness. Anito-cel is a type of CAR T-cell therapy that targets BCMA, a protein on certain immune cells. The trial will enroll 30 adults to check safety and see if it improves daily living activities.

What this could mean

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

Active substance
anitocabtagene autoleucel (CAR T-cell therapy)
What this could lead to
If it works, this could point toward a new treatment option for generalized myasthenia gravis that targets the root cause of the disease.
What could go wrong
This is a very early phase 1 trial with only 30 people, so it is too soon to know if it is safe or effective. CAR T-cell therapy can cause serious side effects like cytokine release syndrome.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 30 people

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

Started

Apr 2025

Expected to finish

Apr 2028

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 years and older

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.

Inclusion Criteria: * Subject must be 18 years of age or older * Must have MGFA clinical classification Grades 2-4A at time of screening * Subject must have clinically active disease and requiring ongoing therapy for GMG * MG-ADL score 6 and QMG score \>10 at screening * GMG specific autoantibodies must be above the reference laboratory ULN Exclusion Criteria: * Subject is pregnant or breastfeeding * Treatment with Anti-CD20 agents, calcineurin inhibitors, FcRN inhibitors, azathioprine, mycophenolate mofetil, methotrexate, or cyclophosphamide within the specified time frame prior to leukapheresis or prior to anito-cel infusion * Previous treatment with any gene therapy, chimeric antigen receptor therapy or T cell engager * Previous thymectomy within 6 months of screening * Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator

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Conditions

The condition(s) this trial relates to.

autoimmune disease autoimmune disorder of the nervous system muscle tissue disorder Muscle Weakness myasthenia gravis Neuromuscular Manifestations

As listed by the trial registrant

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

Autoimmune Autoimmune diseases Autoimmune diseases of the nervous system Muscle weakness Muscular diseases Myasthenia gravis Neuromuscular manifestations

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Karmanos Cancer Institute

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Ohio State University

    RECRUITING

    Columbus, Ohio, 43221, United States

  • Oregon Health & Science University (OHSU)

    RECRUITING

    Portland, Oregon, 97239, United States

  • Stanford Hospital

    RECRUITING

    Palo Alto, California, 94305, United States

  • Temple University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19140, United States

  • UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of California, Irvine

    RECRUITING

    Orange, California, 92602, United States

  • University of Minnesota Delaware Clinical Research Unit

    RECRUITING

    Minneapolis, Minnesota, 55414, United States

  • University of South Florida - Carol and Frank Morsani Center of Advanced Healthcare

    RECRUITING

    Tampa, Florida, 33612, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.