A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Subjects With Refractory Generalized Myasthenia Gravis

• Status: Not yet recruiting
• Trial end date: 2027-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kyverna Therapeutics
• Treatments: Cyclophosphamide; Fludarabine

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

Key Exclusion Criteria

1. Prior treatment with cellular therapy (CAR-T) or gene therapy product directed any target

2. History of allogeneic or autologous stem cell transplant

3. Evidence of active hepatitis B or hepatitis C infection

4. Positive serology for HIV

5. Primary immunodeficiency

6. History of splenectomy

7. History of stroke, seizure, dementia, Parkinson's disease, cerebellar diseases, psychosis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject

8. Impaired cardiac function or clinically significant cardiac disease

9. Previous or concurrent malignancy with the following exceptions:

1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening)

2. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening

3. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening