GT Biopharma, Inc. (NASDAQ: GTBP) has announced the dosing of the first patient in a Phase 1 clinical trial evaluating GTB-3650, a second-generation TriKE (Tri-specific Killer Engager), for the treatment of relapsed or refractory (r/r) CD33-expressing hematologic malignancies. This trial marks a significant step forward in the development of novel immunotherapies for patients with limited treatment options.
The Phase 1 dose-escalation study aims to assess the safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells, and clinical activity of GTB-3650. Up to 14 patients across seven cohorts with r/r CD33-expressing hematologic malignancies, including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS), will be enrolled. GTB-3650 will be administered in two-week blocks, with two weeks on and two weeks off, for up to four months, contingent on clinical benefit. The trial is registered on clinicaltrials.gov under the identifier NCT06594445.
Advancing NK Cell Engager Technology
GTB-3650 represents GT Biopharma's next-generation TriKE platform, incorporating camelid nanobody technology. This innovative approach has the potential to enhance potency and improve binding affinity to target cells, potentially leading to more effective tumor cell killing. The TriKE platform is designed to harness and enhance the cancer-killing abilities of a patient’s immune system’s natural killer (NK) cells.
Management Perspective
"We are thrilled to initiate patient dosing with GTB-3650 in the Phase 1 trial to evaluate the potential in patients with hematological malignancies, which represents a significant milestone for the company," stated Michael Breen, Executive Chairman and interim Chief Executive Officer of GT Biopharma. "As we continue to progress through clinical development, we eagerly anticipate sharing initial data from the study in 2025."
About GT Biopharma
GT Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of immuno-oncology therapeutic products based on its proprietary TriKE® NK cell engager platform. The company has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE technology.
