GT Biopharma, Inc. (NASDAQ: GTBP) announced that its first‑in‑human Phase 1 study of the CD33‑targeted TriKE, GTB‑3650, has progressed to Cohort 4, administering a 10 µg/kg/day dose—the highest level reached to date and the threshold at which preclinical data suggest clinical efficacy may emerge.
The trial, registered under ClinicalTrials.gov identifier NCT06594445, plans to enroll up to 14 patients across seven dose‑escalation cohorts ranging from 1.25 µg/kg/day to 100 µg/kg/day. Six patients have already been treated across the first three cohorts, and no dose‑limiting toxicities have been observed, providing a strong safety signal as the program moves into the next dose level.
Immunologic biomarker analyses at the 10 µg/kg/day level have shown encouraging trends, indicating that the TriKE is engaging natural killer cells and activating anti‑leukemic activity. These data support the hypothesis that the 10 µg/kg/day dose is within the therapeutic window identified in preclinical studies.
The advancement validates GT Biopharma’s second‑generation camelid nanobody TriKE platform and strengthens the company’s narrative for future development and partnership opportunities. While the IND for GTB‑3650 was filed in December 2023 and cleared in June 2024, the current milestone demonstrates that the drug is progressing through its clinical program as planned, reinforcing confidence in the platform’s translational potential.
Executive Chairman and CEO Michael Breen noted, “Reaching Cohort 4 without dose‑limiting toxicities confirms the safety profile we have seen in early cohorts and positions us to evaluate higher doses that may translate into clinical benefit. We remain focused on advancing the program and engaging with potential partners to accelerate development.”
The announcement adds to a series of positive updates that have bolstered investor confidence in GT Biopharma’s pipeline and strategic direction.
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