Official Title: AUTOLOGOUS T-CELLS EXPRESSING A CHIMERIC ANTIGEN RECEPTOR DIRECTED TO B-CELL MATURATION ANTIGEN (BCMA) IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS (MG)
A Study On:
Other
Study Description
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
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
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.
Interested in Participating in this Trial?
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Privacy Policy
University of California, Irvine - Study Information Sheet
UCI Center for Clinical Research Potential Participant Database
Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research
In the instance of parental permission, “You” refers to “Your child.”
Please read the information below and ask questions about anything that you do not understand. A
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While the research team will make every effort to keep your personal information confidential, it is
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Future Research Use
Researchers will use your information to conduct this study. Once the study is done using your
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Data Retention - In accordance with UC Office of the President policy, information will be retained for
10 years after the end of the calendar year in which the research is completed.
If, during the course of this study, significant new information becomes available that may relate to
your willingness to continue to participate, this information will be provided to you by the research
team listed at the top of the form.
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contact the researchers listed at the top of this form
Please contact the UCI Institutional Review Board by phone, (949) 824-8170, by e-mail at
IRB@research.uci.edu or at 160 Aldrich Hall, Irvine, CA 92697-7600 if you are unable to reach the
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The IRB’s role is to protect the rights and welfare of human subjects involved in
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