ClinicaliQ Trial Snapshot
- Study to Assess Safety, Efficacy, and Cellular Kinetics of YTB323 in Generalized Myasthenia Gravis — Recruiting • Phase I • Oncology • NCT06704269.
- Treatment being tested: YTB323, a novel CAR-T cell therapy designed to target and eliminate autoreactive B cells in treatment-resistant generalized myasthenia gravis (gMG), representing a potentially disease-modifying approach for patients failing conventional immunosuppression.
- Patient eligibility overview: The trial focuses on adults with generalized myasthenia gravis who have demonstrated inadequate response or intolerance to standard treatments, filling a critical gap for this difficult-to-manage patient population with limited therapeutic options.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This is a phase I/II study to assess safety, efficacy, and cellular kinetics of YTB323 in participants with treatment-resistant generalized myasthenia gravis. YTB323 is a Biological CAR-T cell therapy.
Eligibility Snapshot
- : 1. 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 2. MGFA Class III-IVa (gMG) at screening 3. Treatment-resistant gMG as defined by: MG-ADL score ≥ 6 (≥50% non-ocular) at screening despite adequate treatment trials with at least two different non-steroidal immunosuppressive drugs given at adequate doses and duration of therapy. 4. If on chronic corticosteroids, must be on a stable dose of corticosteroids for ≥1 month prior to screening and have the ability and willingness to taper to a maximum dose of 10 mg prednisolone daily or equivalent at least one week before leukapheresis 5. If treated with cholinesterase inhibitors, patients must be on a stable dose for at least two weeks prior to screening
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.