Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma

Description

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

Trial Eligibility

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.

Study Info

Interventions

Locations Recruiting

Interested in joining this trial?

Our dedicated patient navigators are here to guide you through the validation and enrollment process with ease.