- GT Biopharma (GTBP, Financial) successfully completes Cohort 1 of its Phase 1 trial for GTB-3650 without safety concerns.
- The trial shows early signs of increased immunologic activity, enabling the transition to Cohort 2.
- Complete trial results are anticipated in 2025 following additional cohort completions.
GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company, announced significant progress in its Phase 1 dose escalation trial of GTB-3650, a second-generation TriKE® natural killer (NK) cell engager. This trial is focused on treating relapsed or refractory CD33-expressing hematologic malignancies.
The company successfully completed dosing in Cohort 1, with no observed safety or tolerability issues, allowing the advancement to Cohort 2. Preliminary data from Cohort 1 indicated promising early signals of increased immunologic activity, showcasing GTB-3650’s ability to activate and expand NK cells, critical indicators of the drug's potential efficacy.
GT Biopharma aims to evaluate approximately 14 patients across seven cohorts, employing a dosing schedule of two weeks on and two weeks off, spanning up to four months. More comprehensive trial results are expected later in 2025 as additional cohorts are completed.
This methodical trial progression underscores a careful approach to establishing the safety profile of GTB-3650, an essential step before evaluating efficacy in subsequent stages. The transition to Cohort 2 represents a crucial milestone for GT Biopharma, with the possibility of dose-limiting toxicities still under observation as dosing escalates.
