Drug intelligence / Profile preview

GTB-3650 TriKE

Development stage
Unknown
Lead developer
GT Biopharma
Modality
Fc-Fusion Proteins → Carrier/Scaffold Proteins → Recombinant Proteins and Enzymes, Nanobodies (VHH) → Antibody Fragments → Engineered Antibody Formats → Antibody-Based Therapeutics
Administration
Intravenous
01

Overview

GTB-3650 TriKE is a second-generation tri-specific killer engager (TriKE) developed by GT Biopharma for the treatment of CD33-positive hematological malignancies, including relapsed or refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The molecule is a recombinant fusion protein consisting of a camelid-derived nanobody targeting CD16 on natural killer (NK) cells, a single-chain variable fragment (scFv) targeting CD33 on myeloid leukemia cells, and a wild-type human IL-15 linker. This configuration allows the drug to simultaneously bridge NK cells to tumor cells while providing a localized IL-15 signal to promote NK cell proliferation, survival, and enhanced cytolytic activity. As of early 2025, GTB-3650 is in Phase 1 clinical development following IND clearance and the initiation of patient enrollment.

Other names
GTB-3650 TriKEGTB3650 TriKEGTB 3650 TriKE
02

Targets

IL-15R (Interleukin 15 receptor alpha/interleukin 15 complex)FCGR3A (Low affinity immunoglobulin gamma Fc region receptor III-A)FCGR3B (Low affinity immunoglobulin gamma Fc region receptor III-B)CD33 (Myeloid cell surface antigen CD33)

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