This study is a Phase 1, open-label, dose escalation, and cohort expansion study designed
to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics,
immunogenicity, and preliminary anti-leukemic activity of WU-NK-101 in R/R AML.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05470140.
Locations matching your search criteria
United States
Maryland
Baltimore
University of Maryland/Greenebaum Cancer CenterStatus: Active
Contact: Natalie Phelps McNally
Phone: 410-328-2341
This is a first in human, multi-center Phase 1 single agent study in patients with R/R
AML who have exhausted other treatment options. The study will consist of two phases,
dose escalation and cohort expansion. During the Dose Escalation Phase, up to 18 patients
will be treated with WU-NK-101 in up to 3 Dose Levels (DL) until maximum tolerated dose
(MTD) or maximum administered dose (MAD) is determined.
Once the MTD/MAD is defined, 6 additional patients will be enrolled in the Cohort
Expansion Phase to further characterize the safety, tolerability, as well as determining
the recommended phase 2 dose (RP2D) of WU-NK-101. Patients in the Cohort Expansion Phase,
who achieve a partial response (PR), may receive up to 2 further re-induction cycles
contingent on safety in the Dose Escalation Phase; patients who achieve a complete
remission with partial hematologic recovery (CRh) or complete remission with incomplete
hematologic recovery (CRi) at any point during the course of treatment may receive a
further consolidation cycle, for a total of up to 4 cycles per patient. During cohort
expansion, dosing breaks of up to two weeks are allowed between cycles.
Lead OrganizationWugen, Inc.
