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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    30
  • sponsor
    Cartesian Therapeutics
Updated on 19 February 2021
platelet count
fludarabine
cyclophosphamide
measurable disease
bone marrow procedure
serum proteins
proteasome inhibitor
plasmacytoma
immunomodulatory imide drug
bcma
bone marrow plasma cells

Summary

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.

Details
Condition Multiple Myeloma, Lymphoproliferative Disorder, Lymphoproliferative disorders, multiple myeloma (mm)
Treatment cyclophosphamide, Fludarabine, Descartes-08
Clinical Study IdentifierNCT03448978
SponsorCartesian Therapeutics
Last Modified on19 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

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
Clear my responses

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