Drug intelligence / Profile preview

GTB-3650

Development stage
Phase 1
Lead developer
GT Biopharma
Modality
Recombinant Proteins and Enzymes, Trispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics, Vaccines & Immunotherapeutics
Administration
Intravenous (continuous Infusion)
01

Overview

GTB-3650 is a second-generation TriKE (Tri-specific Killer Engager) immunotherapy designed to activate and expand endogenous natural killer (NK) cells for the treatment of relapsed or refractory CD33-expressing hematologic malignancies, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The drug leverages GT Biopharma’s proprietary TriKE platform, which aims to harness the cancer-killing abilities of NK cells by engaging them directly with tumor cells expressing CD33. GTB-3650 is currently being evaluated in a Phase 1 dose-escalation clinical trial, where it is administered in two-week blocks via continuous infusion. Early results indicate increased immunologic activity and expansion of NK cells without significant safety concerns[1][2][4][5][6][7][8].

Other names
TriKETri-specific Killer EngagerCD16-CD33-IL-15 TriKECD-16-CD33-IL-15 TriKECD 16-CD33-IL-15 TriKEGTB-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)CD33 (Myeloid cell surface antigen CD33)

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