HM2023-05: GTB-3650 Trike for High Risk MDS and R/R AML

This is a Phase I dose finding study of GTB-3650 (anti-CD16/IL-15/anti-CD33) Tri-Specific Killer Engager (TriKE®) for the treatment of select CD33-expressing refractory/relapsed myeloid malignancies in adults ≥ 18 years of age who are not a candidate for potentially curative therapy, including hematopoietic stem cell transplantation, and are refractory to, intolerant of, or ineligible for therapy options that are known to provide clinical benefit. The hypothesis is GTB-3650 TriKE will induce natural killer (NK) cell function by targeting malignant cells, as well as, CD33+ myeloid derived suppressor cells (MDSC) which contribute to a tumor induced immunosuppression. Because CD16 is the most potent activating receptor on NK cells, this single agent may induce a targeted antiCD33+ tumor response

NCT Number	NCT06594445
Lead Sponsor	Masonic Cancer Center, University of Minnesota
Conditions	Myeloid Malignancy, Acute Myeloid Leukemia, Myelodysplastic Syndromes
Enrollment	45 participants
Start Date	2024-11-19
Primary Completion	2027-03-30 (estimated)
Study Completion	2027-10-30 (estimated)
Updated on ClinicalTrials.gov	2026-07-14