Decartes-08 for Myasthenia Gravis

OGOUS T-CELLS EXPRESSING A CHIMERIC ANTIGEN RECEPTOR
DIRECTED TO B-CELL MATURATION ANTIGEN (BCMA) IN PATIENTS
WITH GENERALIZED MYASTHENIA GRAVIS (MG)

medical-cross
Myasthenia gravis
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All genders
person-wave 18+
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Overview
Principal Investigator: Mithlia Vullaganti, MD; Taha Bali, MD

This is a Phase 2b 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 GMG. The cell product will be referred to as "Descartes-08".

Study details
Inclusion Criteria
  • 1. Patient must have GMG, defined as MGFA clinical classification grade 3 or 4 at the time of screening.
  • 2. Taking immunosuppressive drugs must be deemed necessary by the investigator.
  • 3. If taking corticosteroids, must not exceed 40 mg/day of prednisone equivalent. The dose must have been stable for a minimum of 4 weeks prior to baseline visit
Exclusion Criteria
  • 1. 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
  • 2. Treatment with IVIg or plasma exchange within 4 weeks prior to the baseline (Day 1) visit
  • 3. Treatment with rituximab (RITUXAN) within 12 months prior to baseline (first infusion) visit; treatment
    with ocrelizumab (OCREVUS) or calcineurin inhibitors within 3 weeks prior to planned leukapheresis and within 8 weeks prior to baseline (first infusion) visit
Study Requirements

During the screening process, there is one blood collection for leukapherisis and cell processing. After blood is collected, the subject is randomized to either Decartes-08 or placebo group. The subject and provider are blinded to the group assignment. There will be 6 infusions and 6 follow-up visits for each group. At day 85, the subject and study team will be unblinded. Patients on placebo will be offered Decartes-08 and have 6 additional infusions and 6 follow up visits. This study will last approximately 12 months.