About this trial
This study is a single-center, prospective, nonrandom, single-arm trial.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-65 years old, including the boundary value, no gender restriction;
MGFA clinical class II-IV;
Anti-acetylcholine-receptor antibody (AChR-Ab) shows positive;
Willing to participate in the study, understand and sign the informed consent form (ICF).
Disqualifiers
Received IVMP, IVIG, or TPE within the 2 months before the current visit;
Unable to cooperate in completing the MG-ADL, or QMG, or Quantitative QMG questionnaire.
Judged by a senior clinician to have any of the following: 1)Severe or chronic urinary-tract infection; 2)History of recurrent infections; 3)Previous allergy to any human-derived biologic drug; 4)Depression, suicidal ideation, or other psychiatric disorder;
Patients with active infection, such as herpes zoster, HIV, active tuberculosis, or active hepatitis.
Trial design
Single group
Treatments tested in this trial
CD19-CAR-NK Cells Injection
DrugAllogeneic CD19-CAR-NK cells will be administered intravenously at a fixed dose, once every two weeks for a total treatment duration of 24 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Adverse Events
Incidence and severity of adverse events from subjects during the trial.
Secondary outcomes
Myasthenia Gravis Activities of Daily Living Scores
Changes in myasthenia gravis activities of daily living scores from baseline at every 2-week on-treatment visit and each follow-up, including mean change and symptom fluctuation.
Quantitative Myasthenia Gravis Scores
Changes in quantitative myasthenia gravis scores from baseline at every 2-week on-treatment visit and each follow-up, including mean change and symptom fluctuation.
Myasthenia Gravis Foundation of America Post-intervention Status
Changes in myasthenia gravis foundation of America post-intervention status from baseline at every 2-week on-treatment visit and each follow-up.
AChR-antibody titers
Changes in AChR-antibody titers from baseline at every 2-week on-treatment visit and each follow-up.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: