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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)

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Trial Profile

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 of Trial: Phase I

Latest Information Update: 12 Mar 2026

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At a glance

  • Drugs GTB 3650 (Primary)
  • Indications Acute myeloid leukaemia; Haematological malignancies; Myelodysplastic syndromes
  • Focus Adverse reactions

Most Recent Events

  • 02 Mar 2026 According to a GT Biopharma media release, The Company anticipates providing the next update in the third quarter of 2026, which would include longer term follow-up on the six patients in Cohort 1 through 3 as well as initial observations from patients in Cohort 4 and Cohort 5. Dose escalation may continue up to Cohort 7 as necessary with the potential to evaluate GTB-3650 in a total of 14 patients (two patients per cohort).
  • 02 Mar 2026 According to a GT Biopharma media release,Enrollment in Cohort 4 (10 µg/kg/day) is ongoing, and the Company expects to initiate dosing in Cohort 5 (25 µg/kg/day) in Q2 2026.
  • 23 Oct 2025 According to a GT Biopharma media release, company is actively screening patients for Cohort 4; anticipate initiation of dosing in the coming weeks

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