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Myasthenia GravisPhase 2/3NCT06193889

KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis

A Phase 2/3 study testing Standard lymphodepletion regimen and KYV-101 in people with Myasthenia Gravis and Generalized Myasthenia Gravis, run by Kyverna Therapeutics at 22 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Standard lymphodepletion regimen and KYV-101
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
22 sitesin 6 countries
Study dates
28 Aug 2024to Sep 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Presence of autoantibodies to AChR or MuSK
  • Myasthenia Gravis Foundation of America (MGFA) Class II-IV
  • MG-Activities of Daily Living (MG-ADL) total score of ≥6 at screening and confirmed at baseline visit
  • QMG total score of ≥11 at screening an confirmed at baseline visit
  • 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
  • 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
Show all 10Show fewer
  • No change in dose of acetylcholinesterase inhibitors for ≥2 weeks prior to screening
  • 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)
  • No use of rituximab (or any other anti-CD20 or CD19 monoclonal antibody) within 12 weeks prior to screening
  • Able and willing to attend the necessary visits to the study site

Who cannot join

  • Unable to washout or interrupt autoimmune disease therapy prior to apheresis and/or baseline if required
  • 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)
  • 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
  • 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
  • History of primary immunodeficiency, organ or allogeneic bone marrow transplant, or splenectomy
  • Active, uncontrolled, viral, bacterial, or systemic fungal infection or recent history of repeated infections
Show all 9Show fewer
  • Thymectomy <12 months of screening or planned during the study
  • Prior treatment with gene therapy product or cellular immunotherapy (eg, CAR T) requiring vector integration and directed at any target
  • Patients requiring chronic anticoagulation therapy that cannot be discontinued for medical procedures

Trial locations and contacts

22 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Kyverna Therapeutics, Inc. contact

510-925-2484

Clinicaltrials@kyvernatx.com

22 sites in 6 countries

United States10 sites, 10 recruiting

  • University of Missouri

    Columbia, Missouri, 65212

    Study Coordinator

    Recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Study Coordinator

    Recruiting

  • Indiana University Health

    Indianapolis, Indiana, 46202

    Study Coordinator

    Recruiting

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

    Study Coordinator

    Recruiting

  • University of Miami

    Miami, Florida, 33149

    Study Coordinator

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107

    Study Coordinator

    Recruiting

  • University of California, Irvine

    Orange, California, 92868

    Study Coordinator

    Recruiting

  • Stanford University Medical Center

    Palo Alto, California, 94305

    Study Coordinator

    Recruiting

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    Study Coordinator

    Recruiting

  • Oregon Health & Science University

    Portland, Oregon, 97239

    Study Coordinatory

    Recruiting

Other trials in United States

Germany7 sites, 7 recruiting

  • Charite- Universitätsklinikum Berlin

    Berlin

    Study Coordinator

    Recruiting

  • Universitätsklinikum der Ruhr-Universität Bochum

    Bochum

    Study Coordinator

    Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

    Study Coordinator

    Recruiting

  • Medizinische Hochscule Hannover

    Hanover

    Study Coordinator

    Recruiting

  • Friedrich-Schiller-Universität Jena

    Jena

    Study Coordinator

    Recruiting

  • Universitätsklinik Magdeburg

    Magdeburg

    Study Coordinator

    Recruiting

  • Technical University Munich, Klinikum Rechts der Isar

    Munich

    Study Coordinator

    Recruiting

Other trials in Germany

United Kingdom2 sites, 2 recruiting

  • Cambridge University Hospital, Addenbrooke's Hospital

    Cambridge

    Study Coordinator

    Recruiting

  • King's College Hospital

    London

    Study Coordinator

    Recruiting

Other trials in United Kingdom

Australia1 site, 1 recruiting

  • Westmead Institute for Medical Research

    Westmead

    Study Coordinator

    Recruiting

Other trials in Australia

Brazil1 site, 1 recruiting

  • Hospital Israelita Albert Einstein

    São Paulo

    Study Coordinator

    Recruiting

Other trials in Brazil

Saudi Arabia1 site, 1 recruiting

  • King's Faisal Specialist Hospital and Research Center

    Riyadh, Kindom of Saudi Arabia

    Study Coordinator

    Recruiting

Other trials in Saudi Arabia

About this study

Official title: KYSA-6: A Phase 2/3, Open-Label, Randomized, Controlled, Multicenter Study of KYV-101, an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T-cell (CD19 CAR T) Therapy, Versus Ongoing Standard-Of-Care Immunosuppressive Therapy in Patients With Generalized Myasthenia Gravis

A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis

Read the detailed description

Myasthenia gravis (MG) is a chronic autoimmune disease that affects the neuromuscular junction and is characterized by muscle weakness. B cells play a role in MG, and the disease is characterized by the presence of autoantibodies such as anti-AChR and anti-MuSK antibodies. CD-19 target chimeric antigen receptor (CAR) T cells harness the ability of cytotoxic T cells to directly and specifically lyse target cells to effectively deplete both normal and autoreactive B cells in the circulation as well as impacted lymphoid and potentially non-lymphoid tissues. KYV-101 (mivocabtagene autoleucel [miv-cel])), a fully human anti-CD19 CAR T-cell therapy, will be investigated in adult subjects with myasthenia gravis (MG).

Being tested
Standard of Care Treatment, Standard lymphodepletion regimen, KYV-101
Keywords
KYV-101, myasthenia gravis, autoimmune disease, anti-CD19 CAR-T Therapy, cellular therapy, MG, KYSA-6, KYV101-006, mivocabtagene autoleucel, miv-cel
Medical subject headings
Myasthenia Gravis, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of Care TreatmentDrug

    Standard of Care Medications Optional Crossover to receive KYV-101 treatment

  • Standard lymphodepletion regimenDrug

    Also called Cyclophosphamide, Fludarabine

    Standard lymphodepletion regimen

  • KYV-101Biological

    Anti-CD19 CAR-T cell therapy

Study groups in NCT06193889
Study groupRoleWhat they receive
KYV-101 CAR-T cells with lymphodepletion conditioningExperimentalPhase 2: Dosing with KYV-101 CAR-T cells
Receives: Drug: Standard lymphodepletion regimen; Biological: KYV-101
KYV-101 TreatmentExperimentalPhase 3
Receives: Drug: Standard lymphodepletion regimen; Biological: KYV-101
Standard of CareActive comparatorPhase 3 Optional crossover to receive KYV-101 Treatment after 24 weeks
Receives: Drug: Standard of Care Treatment; Drug: Standard lymphodepletion regimen; Biological: KYV-101

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events (AEs) and laboratory abnormalities (Phase 2)

    Measured: 18 months

  2. Efficacy of KYV-101 via Myasthenia Gravis Activities of Daily Living (MG-ADL) change from baseline (Phase 2)

    Measured: 24 weeks

  3. Efficacy of KYV-101 via Myasthenia Gravis Activities of Daily Living (MG-ADL) change from baseline for KYV-101 Treatment arm to Standard of Care arm (Phase 3)

    Measured: 24 weeks

  4. Efficacy of KYV-101 via Quantitative Myasthenia Gravis (QMG) change from baseline for KYV-101 Treatment arm to Standard of Care arm (Phase 3)

    Measured: 24 weeks

Secondary outcomes (7)

  1. Efficacy of KYV-101 via Myasthenia Gravis Composite (MGC) score change from baseline for KYV-101 Treatment arm to Standard of Care arm (Phase 3)

    Measured: 24 weeks

  2. Efficacy of KYV-101 via Percent change from baseline in anti acetylcholine receptors (anti-AChR) antibody levels for KYV-101 Treatment arm to Standard of Care arm (Phase 3)

    Measured: 24 weeks

  3. Efficacy of KYV-101 via Percent change from baseline in anti muscle-specific tyrosine kinase (anti-MuSK) antibody levels for KYV-101 Treatment arm to Standard of Care arm (Phase 3)

    Measured: 24 weeks

  4. Efficacy of KYV-101 via Proportion of patients with a ≥3 point improvement from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) for KYV-101 Treatment arm to Standard of Care arm (Phase 3)

    Measured: 24 weeks

  5. Efficacy of KYV-101 via Proportion of patients with minimal symptom expression (MSE) for KYV-101 Treatment arm to Standard of Care arm (Phase 3)

    Measured: 24 weeks

  6. Efficacy of KYV-101 via Myasthenia Gravis Quality of Life 15-item Scale (MG-QoL 15r) change from baseline for KYV-101 Treatment arm to Standard of Care arm (Phase 3)

    Measured: 24 weeks

  7. Incidence and severity of adverse events (AEs) and laboratory abnormalities (Phase 3)

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start28 Aug 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06193889
Sponsor's protocol ID
KYSA-6
Other IDs
KYV101-006
Status last verified
Jul 2026
First submitted
11 Oct 2023
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gilhus NE, Tzartos S, Evoli A, Palace J, Burns TM, Verschuuren JJGM. Myasthenia gravis. Nat Rev Dis Primers. 2019 May 2;5(1):30. doi: 10.1038/s41572-019-0079-y.

    PubMed 31048702

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Standard lymphodepletion regimen and KYV-101 in people with Myasthenia Gravis and Generalized Myasthenia Gravis, run by Kyverna Therapeutics at 22 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States, Germany, United Kingdom, Australia, Brazil and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kyverna Therapeutics, Inc. (510-925-2484, Clinicaltrials@kyvernatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (AEs) and laboratory abnormalities (Phase 2) (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06193889, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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