Autologous CD8+ T-cells Expressing an Anti-BCMA CAR in Patients With Myeloma
Combined Phase I-Phase II Study of Autologous CD8+ T-cells Transiently Expressing a Chimeric Antigen Receptor Directed to B-Cell Maturation Antigen in Patients With Multiple Myeloma
  • Phase

    Phase 1
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

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.
Study Started
Feb 26
Primary Completion
Dec 26
Study Completion
Dec 31
Last Update
Mar 11

Biological Descartes-08

autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor

  • Other names: CAR-T cells

Drug Fludarabine

intravenous fludarabine

Drug Cyclophosphamide

intravenous cyclophosphamide

Descartes-08 plus fludarabine/cyclophosphamide pretreat Experimental

Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor


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
No Results Posted