Multiple Myeloma Clinical Trial
Descartes-15 for Patients With Relapsed/Refractory Multiple Myeloma
Summary
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
Eligibility Criteria
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.
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There is 1 Location for this study
Bethesda Maryland, 20817, United States
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