San Francisco, California — August 11, 2025 — Leads & Copy — GT Biopharma, Inc. (NASDAQ: GTBP) has announced the start of dosing for Cohort 3 in its Phase 1 dose escalation trial. The trial is evaluating GTB-3650 for treating relapsed or refractory CD33 expressing hematologic malignancies. The first patient in Cohort 3 has completed the first week of cycle 1, following a successful safety review of Cohort 2, which showed no safety or tolerability issues.
The Phase 1 trial is assessing GTB-3650, GT Biopharma’s second-generation TriKE, in up to 14 patients across seven cohorts. GTB-3650 will be administered in two-week blocks, with two weeks on and two weeks off, for up to four months based on clinical benefit. The trial will monitor safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells, and clinical activity. Initial Phase 1 results are expected later in 2025, after completing additional dose cohorts. Cohorts 1 and 2 have been completed with encouraging early results showing GTB-3650’s ability to activate endogenous NK cells and induce NK cell expansion. Data from multiple blood biomarker assays from the first four patients show heightened immune activity. Details are available on clinicaltrials.gov (identifier: NCT06594445).
GT Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing immuno-oncology therapeutics based on its TriKE® NK cell engager platform. The TriKE® platform enhances the cancer-killing abilities of a patient’s natural killer cells. GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology.
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