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CYNK-101

Cell therapy (NK cells) · Kills target cells, directed at HER2 (ERBB2) · developed by Celularity

Phase 1/2 Most advanced trial (none active)

CELU Developer

1 Registered trials

What is CYNK-101?

CYNK-101 is an off-the-shelf allogeneic NK cell therapy derived from human placental hematopoietic stem cells and engineered to express high-affinity CD16 (hnCD16). The cells enhance antibody-dependent cellular cytotoxicity when combined with tumor-targeting monoclonal antibodies. It is being studied in metastatic HER2-positive gastroesophageal junction cancer.

Summary written with AI from the sources listed at the end of this page.

At a glance

Drug type: Cell therapy (NK cells)
Targets: HER2 (ERBB2) (biomarker)
Mechanism: Kills target cells, directed at HER2 (ERBB2)
Pathways: antibody-dependent cellular cytotoxicity (ADCC), NK cell activation
Therapy area: Oncology
Developer: Celularity Incorporated (CELU)
FDA status: Investigational, not approved in the US. Most advanced trial: Phase 1/2

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT05207722	Phase 1/2	Metastatic HER2 Positive Gastroesophageal Junction Cancer	Terminated	CELU

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Metastatic HER2 Positive Gastroesophageal Junction Cancer

Other drugs acting on ERBB2

Neratinib FDA approved Trastuzumab Deruxtecan FDA approved Trastuzumab Emtansine FDA approved Zanidatamab FDA approved ADCT-502 Phase 1 BH-30643 Phase 1/2 CGT4255 Phase 1 CUDC-101 Phase 1 ELVN-002 Phase 1 Enozertinib Phase 1/2 NVL-330 Phase 1 TTX-MC138 Phase 1/2

More from Celularity

PDA-002 Phase 2 PDA001 Phase 2 Taniraleucel Phase 1/2

Sources

Updated Oct 3, 2026. Something wrong or missing? Report it on the CELU page.

Follow CELU, the company behind CYNK-101

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z