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Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma

Trial Status: Active

This Phase I / II study will test the safety and anti-myeloma activity of ascending doses of Descartes-08 (autologous CD8+ T-cells expressing an anti-BCMA chimeric antigen receptor) in eligible patients with active multiple myeloma.

Inclusion Criteria

  • Inclusion Criteria (condensed): - Multiple myeloma that is double-refractory to a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) after at least 2 prior lines of therapy OR have failed at least 3 prior lines of therapy - Measurable disease activity as indicated by serum or urine M-protein, serum free light chain, biopsy-proven plasmacytoma, >5% bone marrow plasma cells. - Adequate vital organ function as indicated by ANC (>1000/uL), platelet count (>50,000/uL), hemoglobin (>8 g/dL), serum ALT and AST (each <3.0 x upper limit of normal), total bilirubin (<2 mg/dL), creatinine clearance (>30 mL/min), and cardiac ejection fraction (>45%) Exclusion Criteria (condensed): NOTE: Prior anti-BCMA or CAR-T therapy is NOT exclusionary - Active plasma cell leukemia - Pregnant or lactating - Active, uncontrolled infection - Active and severe auto-immune disease - Active arrhythmia, or obstructive or restrictive pulmonary disease - Central nervous system disease

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: ACTIVE

New Jersey

Hackensack
Hackensack University Medical Center
Status: ACTIVE

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: ACTIVE

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
Cartesian Therapeutics

  • Primary ID 241-59-88
  • Secondary IDs NCI-2019-01434
  • Clinicaltrials.gov ID NCT03448978