This is a Phase I dose-escalation study to evaluate the safety, tolerability and preliminary efficacy of an autologous BCMA-targeting RNA-engineered CAR T-cell therapy in patients with Relapsed/Refractory Multiple Myeloma. The cell product is referred to as Descartes-15
Patients must be 18 years of age or older at the time of enrollment. Patients must be diagnosed with active and measurable relapsed/refractory multiple myeloma. Patients must have failed at least 3 prior lines of therapy which must have included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 drug or biologic. Failure of treatment and measurable myeloma disease are defined as per 2016 IMWG criteria. Patients must have clinical performance status of ECOG 0-2. Patients must have adequate vital organ function as defined by: Hemoglobin ≥8 g/dL Absolute neutrophil count > 1000/ mm3 Platelets > 50,000/mm3 ALT/AST levels lower than 3-fold of normal Creatinine clearance ≥45 mL/min/1.73 m2 Normal cardiac and pulmonary function No thromboembolic events in the past 3 months No heparin allergy or active infection
Exclusion Criteria
Patients who have any active and uncontrolled infection. Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine or systemic steroids above 40 mg/day prednisone equivalent). Patients who have active central nervous system disease.
