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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: 07 Oct 2025

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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

  • 11 Aug 2025 According to a GT Biopharma media release, the fifth patient in the trial has completed the first week of cycle 1 following a successful safety review of Cohort 2, with no safety or tolerability issues observed. Both Cohorts 1 and 2 have now been successfully completed, and after formal safety reviews, no safety or tolerability concerns were identified. This progress has enabled the initiation of dosing in Cohort 3, with the first patient having just completed the first week of cycle 1.
  • 11 Aug 2025 According to a GT Biopharma media release, company today announced initiation of dosing in Cohort 3 in this Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies. Company plans on releasing initial Phase 1 results later in 2025 following completion of additional dose cohorts.
  • 19 May 2025 According to a GT Biopharma media release, company announced successful completion of dosing in Cohort 1 and subsequent initiation of dosing in Cohort 2 of its Phase 1 dose escalation trial evaluating GTB-3650 for the treatment of relapsed or refractory (r/r) CD33 expressing hematologic malignancies.

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