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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Descartes-08 plus fludarabine/cyclophosphamide pretreat 		Autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
  • 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

More Details

Status
Completed
Sponsor
Cartesian Therapeutics

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.