NCT06594445

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

HM2023-05: GTB-3650 (Anti-CD16/IL-15/Anti-CD33) Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Myeloid Malignancy
• Acute Myeloid Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	GTB-360	GTB-3650 is administered by a continuous infusion (CI). A patient's dose of GTB-3650 is calculated using their assigned Dose Level and their actual body weight (ABW) obtained within 5 days prior to or on Cycle 1, Day 1. Dose Level 1: 1.25 ug/kg/day Dose Level 2: 2.5 ug/kg/day Dose Level 3: 5 ug/kg/day Dose Level 4: 10 ug/kg/day Dose Level 5: 25 ug/kg/day Dose Level 6: 50 ug/kg/day Dose Level 7: 100 ug/kg/day

Timeline

• Start date: 2024-11-19
• Primary completion: 2027-03-30
• Completion: 2027-10-30
• First posted: 2024-09-19
• Last updated: 2025-06-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study