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NKX019 in Subjects with Myasthenia Gravis

Neurology
Ali Habib
A Phase 1 Study of NKX019, a CD19 Chimeric Antigen Receptor Natural Killer (CAR NK) Cell Therapy, in Subjects with Myasthenia Gravis
Myasthenia Gravis

Study Description

Eligibility

Age: 18 - 80 years old at the time of informed consent

Generalized myasthenia gravis (gMG) with Myasthenia Gravis Foundation of America

(MGFA) Class II-IV

Antibody positivity for acetylcholine receptor (AChR) and/or muscle specific kinase

(MuSK) having a titer above the upper limit of normal (ULN)

Key

Treatments for gMG with IVIG and/or PLEX within 4 weeks prior to LD, CD20 monoclonal antibody (eg, rituximab, ocrelizumab), complement inhibitors (eg, ravulizumab not on stable dose for 26 weeks before screening, or eculizumab or zilucoplan not on stable dose for 12 weeks before screening), and/or FcRn inhibitors within 4 weeks prior to LD or during dosing

Previous solid organ or hematopoietic cell transplant or planned transplant within study treatment period

Liver disease or dysfunction, including cirrhosis and/or aspartate aminotransferase, alanine aminotransferase, or bilirubin > 3X ULN

Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision, or a history of thymoma that has been adequately managed

Prior cellular therapy, including mesenchymal, T cell-based, or NK cell-based therapies. Note: Subjects with prior exposure to NKX019 are allowed if entering retreatment.

Please note that this is not an exhaustive list of all inclusion or exclusion criteria, and more may apply at screening.

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