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: 25 Nov 2025

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At a glance

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

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
23 Oct 2025 According to a GT Biopharma media release, company announced successful completion of the Cohort 3 formal safety review with no safety or tolerability issues observed and advancement into Cohort 4.
17 Oct 2025 According to a GT Biopharma media release, the trial will continue escalating doses into higher ranges expected to translate immune activation into meaningful clinical benefits.

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