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

NCT ID: NCT06193889

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-28
• Study Completion Date: 2028-09-30

Brief Summary

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

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, a fully human anti-CD19 CAR T-cell therapy, will be investigated in adult subjects with myasthenia gravis (MG).

Conditions

Myasthenia Gravis; Generalized Myasthenia Gravis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KYV-101 CAR-T cells with lymphodepletion conditioning

Phase 2: Dosing with KYV-101 CAR-T cells

Group Type: EXPERIMENTAL

Standard lymphodepletion regimen

Intervention Type: DRUG

Standard lymphodepletion regimen

KYV-101

Intervention Type: BIOLOGICAL

Anti-CD19 CAR-T cell therapy

KYV-101 Treatment

Phase 3

Group Type: EXPERIMENTAL

Standard lymphodepletion regimen

Intervention Type: DRUG

Standard lymphodepletion regimen

KYV-101

Intervention Type: BIOLOGICAL

Anti-CD19 CAR-T cell therapy

Standard of Care

Phase 3 Optional crossover to receive KYV-101 Treatment after 24 weeks

Group Type: ACTIVE_COMPARATOR

Standard of Care Treatment

Intervention Type: DRUG

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

Standard lymphodepletion regimen

Intervention Type: DRUG

Standard lymphodepletion regimen

KYV-101

Intervention Type: BIOLOGICAL

Anti-CD19 CAR-T cell therapy

Interventions

Standard of Care Treatment

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

Intervention Type: DRUG

Standard lymphodepletion regimen

Standard lymphodepletion regimen

Intervention Type: DRUG

KYV-101

Anti-CD19 CAR-T cell therapy

Intervention Type: BIOLOGICAL

Other Intervention Names

Cyclophosphamide; Fludarabine

Eligibility Criteria

Inclusion Criteria

1. Presence of autoantibodies to AChR or MuSK at screening.

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 pre-dose baseline

4. QMG total score of ≥11 at screening an confirmed at pre-dose baseline

5. Failed treatment with 2 or more immunosuppressive/immunomodulatory therapies, or failed at least 1 immunosuppressive therapy and required chronic plasmapheresis, or IVIG (>4 times/year over ≥12 months) 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. No use of FcRn inhibitors within 4 weeks prior to screening

Exclusion Criteria

1. Unable to washout or interrupt autoimmune disease therapy prior to apheresis

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyverna Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

MD

Role: STUDY_DIRECTOR

Kyverna Therapeutics, Inc.

Locations

University of California, Irvine

Orange, California, United States

Site Status: RECRUITING

Stanford University Medical Center

Palo Alto, California, United States

Site Status: RECRUITING

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Indiana University Health

Indianapolis, Indiana, United States

Site Status: RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Houston Methodist Hospital

Houston, Texas, United States

Site Status: RECRUITING

Intermountain Medical Center

Murray, Utah, United States

Site Status: RECRUITING

Hospital Israelita Albert Einstein

São Paulo, , Brazil

Site Status: RECRUITING

Charite- Universitätsklinikum Berlin

Berlin, , Germany

Site Status: RECRUITING

Universitätsklinikum der Ruhr-Universität Bochum

Bochum, , Germany

Site Status: RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status: RECRUITING

Medizinische Hochscule Hannover

Hanover, , Germany

Site Status: RECRUITING

Friedrich-Schiller-Universität Jena

Jena, , Germany

Site Status: RECRUITING

Universitätsklinik Magdeburg

Magdeburg, , Germany

Site Status: RECRUITING

Countries

United States; Brazil; Germany

Central Contacts

Kyverna Therapeutics, Inc.

Role: CONTACT

Clinicaltrials@kyvernatx.com

510-925-2484

Facility Contacts

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

Study Coordinator

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 31048702 (View on PubMed)

Other Identifiers

KYV101-006

Identifier Type: OTHER

Identifier Source: secondary_id

KYSA-6

Identifier Type: -

Identifier Source: org_study_id