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GT Biopharma Advances into Cohort 3 of GTB-3650 Phase 1 Trial Following Safety Review of Cohort 2
Globenewswireยท 2025-08-11 11:00
Core Insights - GT Biopharma has initiated dosing in Cohort 3 of its Phase 1 dose escalation trial for GTB-3650, targeting relapsed or refractory CD33 expressing hematologic malignancies [1][2] - The first patient in Cohort 3 has completed the first week of cycle 1, following successful safety reviews of previous cohorts with no safety or tolerability issues reported [1][2] - Encouraging early results from Cohorts 1 and 2 indicate GTB-3650's potential to activate endogenous NK cells and induce NK cell expansion, with heightened immune activity observed in multiple blood biomarker assays [3] Trial Details - The Phase 1 trial will evaluate GTB-3650 in approximately 14 patients across seven cohorts, with dosing occurring in two-week blocks for up to four months based on clinical benefit [4] - The trial aims to assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous NK cells, and clinical activity [4] - Initial Phase 1 results are expected to be released later in 2025 after the completion of additional dose cohorts [3] Company Overview - GT Biopharma is a clinical stage biopharmaceutical company focused on developing immuno-oncology therapeutics based on its proprietary TriKE NK cell engager platform [5] - The company holds an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies utilizing TriKE technology [5]