Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma

Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma

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

Inclusion Criteria

• 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.