Trial | NCT03448978  Report issue

Title

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

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    38
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
2018
Primary Completion
Dec 26
2021
Study Completion
Dec 31
2021
Last Update
Mar 11
2022

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

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
No Results Posted