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Status:

TERMINATED

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

Lead Sponsor:

Cartesian Therapeutics

Conditions:

Multiple Myeloma

Eligibility:

All Genders

18+ years

Phase:

PHASE1

Brief Summary

This Phase I 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 wi...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    March 8 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 3 2021

    Estimated Enrollment :

    32 Patients enrolled

    Trial Details

    Trial ID

    NCT03448978

    Start Date

    March 8 2018

    End Date

    June 3 2021

    Last Update

    July 1 2024

    Active Locations (3)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (3 locations)

    1

    The Center for Cancer and Blood Disorders

    Bethesda, Maryland, United States, 20817

    2

    University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, United States, 73104

    3

    Virgina Cancer Specialists

    Fairfax, Virginia, United States, 22031