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 with active multiple myeloma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
intravenous fludarabine
intravenous cyclophosphamide
The Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Virgina Cancer Specialists
Fairfax, Virginia, United States
Incidence (number) of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence (number) of Treatment-Emergent Adverse Events \[Safety and Tolerability\]. Descriptive statistics by incidence rate, body system classification, severity, and causality \[per protocol definitions\]
Time frame: 2 weeks
Treatment response
IMWG treatment response criteria
Time frame: 1, 3, 6, 9 and 12 months
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