Confirmed gMG diagnosis supported by the following:

Documented report of positive serology testing for either AChR antibodies or

MuSK antibodies at screening AND at least one of the following:

History of abnormal neuromuscular transmission test demonstrated by repetitive nerve stimulation or single-fiber electromyography

History of positive acetylcholinesterase inhibitor test

Improvement in MG signs on an oral acetylcholinesterase inhibitor as assessed by the treating physician

MGFA Class III-IVa (gMG) at screening

Treatment-resistant gMG as defined by: MG-ADL score ≥ 6 at screening despite adequate treatment trials with at least two different non-steroidal immunosuppressive drugs given at adequate doses and duration of therapy.

If on chronic corticosteroids, the ability and willingness to taper to a maximum dose of 10 mg prednisolone daily or equivalent at least one week before leukapheresis

If treated with cholinesterase inhibitors, patients must be on a stable dose for at least two weeks prior to screening

YOU CAN'T JOIN IF:

If you've had prior treatment with anti-CD19 therapy, adoptive T cell therapy or any prior gene therapy product (e.g. CAR-T cell therapy).

Other protocol-defined inclusion/exclusion criteria may apply