An open-label study to assess safety, efficacy, and cellular kinetics of YTB323 in treatment-resista

Eligibility

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

Interested in joining this trial?