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CAR t therapy takes on myasthenia gravis in major new trial

NCT ID NCT06193889

Disease control Sponsor: Kyverna Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 30, 2026 · Updated 4 times

Summary

This study tests a new treatment called KYV-101, made from a patient's own immune cells, against standard immunosuppressive drugs for generalized myasthenia gravis. About 66 adults who have not responded to at least two prior therapies will be randomly assigned to receive either KYV-101 or continue standard care. The goal is to see if KYV-101 can better improve daily living and muscle strength while managing side effects.

Why investors are watching

Kyverna Therapeutics is testing KYV-101, a CAR T-cell therapy, against standard immunosuppressive drugs in 66 people with generalized myasthenia gravis. For a micro-cap company with few other products, this phase 2/3 readout is the main driver of its value. A clear result, positive or negative, will likely reshape how investors view the company's future.

If it works: If KYV-101 shows better disease control than standard care, Kyverna could have a new treatment for a chronic autoimmune disease. That result might support further development and eventual regulatory approval, which would be a major asset for a company of this size.

If it fails: Trials often fail, and this one has only 66 participants, so the results may not be conclusive. If KYV-101 does not beat standard care or causes safety problems, Kyverna would face a setback with no clear path forward, and its stock could lose value.

AI-written from the trial record. Speculative, and not investment advice.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 66 people

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

Started

Aug 2024

Expected to finish

Sep 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 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. Presence of autoantibodies to AChR or MuSK 2. Myasthenia Gravis Foundation of America (MGFA) Class II-IV 3. MG-Activities of Daily Living (MG-ADL) total score of ≥6 at screening and confirmed at baseline visit 4. QMG total score of ≥11 at screening an confirmed at baseline visit 5. Failed treatment with 2 or more immunosuppressive/immunomodulatory therapies, or failed at least 1 immunosuppressive therapy and required chronic plasmapheresis, or IVIG (or subcutaneous or intramuscular Ig) to control symptoms 6. On a stable dose of glucocorticoids and/or other immunotherapies for ≥1 month prior to screening. For patients treated with azathioprine, a stable dose for ≥2 months prior to screening is required 7. No change in dose of acetylcholinesterase inhibitors for ≥2 weeks prior to screening 8. No use of intravenous immune globulin (IVIG) or plasmapheresis (PLEX) within 4 weeks of screening or pre-dose baseline (unless this is part of their SOC treatment regimen) 9. No use of rituximab (or any other anti-CD20 or CD19 monoclonal antibody) within 12 weeks prior to screening 10. Able and willing to attend the necessary visits to the study site Key Exclusion Criteria 1. Unable to washout or interrupt autoimmune disease therapy prior to apheresis and/or baseline if required 2. Co-occurring neurological autoimmune disease (ie, Lambert-Eaton Myasthenic Syndrome) or any disease affecting the neuromuscular junction or muscle causing weakness (eg, myositis, myopathy, motor neuropathy) 3. History of stroke (with residual sequalae and/or risk for recurrence), seizure (even if well controlled on antiepileptics), neurodegenerative disease, altered mental status (unexplained and/or recent/current), or uncontrolled/severe psychiatric disease 4. Any serious and/or uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol, including but not limited to, clinically significant cardiac or pulmonary disease 5. History of primary immunodeficiency, organ or allogeneic bone marrow transplant, or splenectomy 6. Active, uncontrolled, viral, bacterial, or systemic fungal infection or recent history of repeated infections 7. Thymectomy \<12 months of screening or planned during the study 8. Prior treatment with gene therapy product or cellular immunotherapy (eg, CAR T) requiring vector integration and directed at any target 9. Patients requiring chronic anticoagulation therapy that cannot be discontinued for medical procedures

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Conditions

The condition(s) this trial relates to.

autoimmune disease myasthenia gravis

As listed by the trial registrant

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

Generalized myasthenia gravis Myasthenia gravis

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    22 sites in 6 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Cambridge University Hospital, Addenbrooke's Hospital

    RECRUITING

    Cambridge, United Kingdom

  • Charite- Universitätsklinikum Berlin

    RECRUITING

    Berlin, Germany

  • Friedrich-Schiller-Universität Jena

    RECRUITING

    Jena, Germany

  • Hospital Israelita Albert Einstein

    RECRUITING

    São Paulo, Brazil

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Indiana University Health

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • King's College Hospital

    RECRUITING

    London, United Kingdom

  • King's Faisal Specialist Hospital and Research Center

    RECRUITING

    Riyadh, Kindom of Saudi Arabia, Saudi Arabia

  • Medizinische Hochscule Hannover

    RECRUITING

    Hanover, Germany

  • Oregon Health & Science University

    RECRUITING

    Portland, Oregon, 97239, United States

  • Ronald Reagan UCLA Medical Center

    RECRUITING

    Los Angeles, California, 90095, United States

  • Stanford University Medical Center

    RECRUITING

    Palo Alto, California, 94305, United States

  • Technical University Munich, Klinikum Rechts der Isar

    RECRUITING

    Munich, Germany

  • Thomas Jefferson University Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • University of California, Irvine

    RECRUITING

    Orange, California, 92868, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33149, United States

  • University of Missouri

    RECRUITING

    Columbia, Missouri, 65212, United States

  • Universitätsklinik Magdeburg

    RECRUITING

    Magdeburg, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

  • Universitätsklinikum der Ruhr-Universität Bochum

    RECRUITING

    Bochum, Germany

  • Westmead Institute for Medical Research

    RECRUITING

    Westmead, Australia

More trials for these conditions

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