Trial Title:
KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Subjects With Refractory Generalized Myasthenia Gravis
NCT ID:
NCT06193889
Condition:
Myasthenia Gravis
Generalized Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Cyclophosphamide
Fludarabine
Conditions: Keywords:
KYV-101
myasthenia gravis
autoimmune disease
anti-CD19 CAR-T Therapy
cellular therapy
MG
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
KYV-101
Description:
Anti-CD19 CAR-T cell therapy
Arm group label:
KYV-101 CAR-T cells with lymphodepletion conditioning
Intervention type:
Drug
Intervention name:
Standard lymphodepletion regimen
Description:
Standard lymphodepletion regimen
Arm group label:
KYV-101 CAR-T cells with lymphodepletion conditioning
Other name:
Cyclophosphamide
Other name:
Fludarabine
Summary:
A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Subjects 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).
Criteria for eligibility:
Criteria:
Key Inclusion Criteria
1. Diagnosis of MG with presence of autoantibodies to AChR and MuSK
2. Myasthenia Gravis Foundation of America (MGFA) Class IIB-IV*
3. MG-Activities of Daily Living (MG-ADL) total score of ≥6 at screening and at
pre-dose baseline
4. Failed treatment over 1 year or more with 2 or more
immunosuppressive/immunomodulatory therapies or; failed at least 1 immunosuppressive
therapy and required chronic plasmapheresis, or IVIG to control symptoms**
5. On a stable dose of glucocorticoids and/or other immunotherapies for ≥1 month prior
to screening. For azathioprine, being on a stable dose for ≥2 months prior to
screening is require
6. No change in dose of acetylcholinesterase inhibitors for ≥2 weeks prior to screening
7. No use of IV Igor plasma exchange (PLEX) within 4 weeks of pre-dose baseline
(*) For Germany Sites: Myasthenia Gravis Foundation of America (MGFA) Class III-IV.
Patients with disease classified as MGFA Class IIB may be included if the patient
requires continuous treatment with IVIG or PLEX to be maintained at MGFA class IIB.
(**) For Germany Sites: In the preceding 2 years failed two monoclonal antibodies with
different mechanisms of action - or - failed at least 1 monoclonal antibody and required
chronic plasmapheresis, or IVIg to control symptoms. Patients are required to have failed
two different monoclonal antibodies as treatment for the preceding 1 to 2 years.
Key Exclusion Criteria
1. Impaired cardiac function or clinically significant cardiac disease including:
1. Unstable angina or myocardial infarction or coronary artery bypass graft within
6 months prior to apheresis
2. New York Heart Association stage III or IV congestive heart failure
3. History of clinically significant cardiac arrhythmia (e.g., ventricular
tachycardia, QTc prolongation, and/or torsades de pointes), complete left
bundle branch block, high-grade atrioventricular block
4. History of severe nonischaemic cardiomyopathy
5. Left ventricular ejection fraction (LVEF) <45% as assessed by echocardiogram
(ECHO) or multi-gated acquisition (MUGA) scan (performed ≤8 weeks of apheresis)
2. Serious and/or uncontrolled medical condition and severity of the underlying MG
disease activity that, in the investigator's judgment, would cause unacceptable
safety risk, interfere with study procedures or results, or compromise compliance
with the protocol, such as:
1. Active, uncontrolled, viral, bacterial, or systemic fungal infection (including
human T -cell lymphotropic virus [HTLV], human polyomavirus 2 [JC virus], or
syphilis); or recent history of repeated infections
2. Clinical evidence of dementia or altered mental status
3. Recent thromboembolic event
4. On anti-coagulation agents that would be unsafe to transiently hold for medical
procedures
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, Irvine
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Stanford University Medical Center
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Intermountain Medical Center
Address:
City:
Murray
Zip:
84107
Country:
United States
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Charite- Universitätsklinikum Berlin
Address:
City:
Berlin
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Universitätsklinikum der Ruhr-Universität Bochum
Address:
City:
Bochum
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Universitätsklinikum Hamburg-Eppendorf
Address:
City:
Hamburg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Medizinische Hochscule Hannover
Address:
City:
Hannover
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Facility:
Name:
Friedrich-Schiller-Universität Jena
Address:
City:
Jena
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Start date:
August 28, 2024
Completion date:
May 2027
Lead sponsor:
Agency:
Kyverna Therapeutics
Agency class:
Industry
Source:
Kyverna Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06193889
