AUTOLOGOUS T-CELLS EXPRESSING A CHIMERIC ANTIGEN RECEPTOR DIRECTED TO B-CELL MATURATION ANTIGEN (BCMA) IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS (MG)
Details
This is a Phase Ib/II study to evaluate the safety, tolerability and preliminary
efficacy of autologous T-cells expressing a chimeric antigen receptor (CAR)
directed to B-Cell maturation antigen (BCMA) in patients with Generalized Myathenia Gravis (GMG). This is a three part study.
Eligibility
You can join if...
Inclusion Criteria:
Patient must be at least 18 years of age.
Patient must have Generalized Myasthenia Gravis at the time of screening.
Concomitant immunosuppressive drugs must be deemed necessary by the investigator.
Seronegative Patients are included
Exclusion Criteria:
Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient.
Patient is pregnant or lactating.
Treatment with IVIg or plasma exchange within 4 weeks prior to the baseline (Day 1) visit.
Treatment with rituximab/ocreluzimab or calcineurin inhibitors, e.g., tacrolimus, cyclosporine or cyclophosphamide or Neonatal Fc receptor antagonists, e.g. efgartigimod. Wash-out period for rituximab is 12 months prior to baseline visit; wash-out period for other agents is 3 weeks before planned leukapheresis and 8 weeks prior to baseline (first infusion) visit.
NOTE: There are ADDITIONAL Inclusion/Exclusion Criteria that potential participants must meet in order to qualify for this trial.