Clinical trials
Full profile accessFollow clinical development from study design and recruitment through results.
- Trial phase
- Status
- Readouts
Drug intelligence / Profile preview
CD16xCD33 BiKE is a fully humanized bispecific antibody construct known as a "bispecific killer cell engager." It binds simultaneously to **CD16** (FcγRIIIa) on natural killer (NK) cells and **CD33** on target cells, primarily malignant myeloid cells. This dual-targeting enables the activation and redirection of NK cells to kill CD33-positive cells by engaging NK cell-mediated cytotoxicity, including degranulation and cytokine production (such as TNF-α and IFN-γ). The drug is being studied as a targeted immunotherapy for **acute myeloid leukemia (AML)**, **biphenotypic acute lymphoblastic leukemia (ALL)** that expresses CD33, and **myelodysplastic syndrome (MDS)**. Preclinical studies and early-phase trials have shown that CD16xCD33 BiKE enhances NK cell effector functions and promotes lysis of CD33^+^ leukemic cells and myeloid-derived suppressor cells. Potential uses include maintenance therapy or as a bridge to hematopoietic stem cell transplantation in pediatric and adult patients[1][2][3].
Beyond the preview
Explore the evidence, development activity, and competitive landscape with Gosset’s full data platform.
Follow clinical development from study design and recruitment through results.
Explore development by indication, patient population, and geography.
Trace asset ownership, licensing agreements, and commercial partnerships.
Explore the patent landscape and regulatory exclusivity around an asset.
Compare development programs by target, modality, and indication.
Connect source evidence and development news to your research questions.
See how Gosset can support your research on CD16xCD33 BiKE.