Study of CD8+ anti-BCMA CAR T-cells in Patients with Multiple Myeloma

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Overview

The main purpose of this study is to evaluate the safety of an investigational CAR-T cell therapy called Descartes-08. The study will also explore whether Descartes-08 provides any treatment benefit in patients with Multiple Myeloma.

SparkCures ID 943
Trial Phase Phase 1
Enrollment 38 Patients
Treatments
Tags
Trial Sponsors
  • Cartesian Therapeutics
NCT Identifier

NCT03448978

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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 < 2.5 3.0 x upper limit of normal), total bilirubin (<2 mg/dL), creatinine clearance (> 60 30 mL/min), and cardiac ejection fraction (> 50 45%)

Exclusion Criteria (condensed):

  • 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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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