Condition: Refractory Acute Myeloid Leukemia (AML) · Relapsed Acute Myeloid Leukemia (AML) · Myelodysplastic Syndrome · Sponsor: University of Colorado, Denver
This is a Phase 1, open label, dose-escalation study to evaluate the safety, expansion, persistence, and preliminary clinical activity of lentivirally transduced autologous T cells expressing anti-CD64 chimeric antigen receptors (CAR) expressing tandem CD3ζ and 4-1BB (CD3ζ/4-1BB) costimulatory domains in subjects with refractory or relapsed (R/R) acute myeloid leukemia (AML). This CAR T cell product will be referred to as "CD64 CAR T" which is CD64 directed, autologous, genetically modified CAR T cells. The primary objective of the study is to identify the safety profile and maximum tolerated dose (MTD) of CD64 CAR T in subjects with R/R AML as determined by the defined DLTs using a standard Bayesian Optimal Interval (BOIN) design.
This description comes directly from the study's public registry record.
Derek Schatz · 720-848-0628 · derek.schatz@cuanschutz.edu
Always discuss trial participation with your own doctor first.
| University of Colorado Hospital | Aurora, Colorado, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07347418