NCT05207722

CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma

Terminated Phase 1, PHASE2 Last updated 12 December 2024

What this trial tests

Phase 1, PHASE2 trial testing CYNK-101 in Metastatic HER2 Positive Gastroesophageal Junction Cancer in 1 participant. Terminated before completion.

Timeline

14 April 2022

Primary endpoint
15 February 2024

15 February 2024

Quick facts

Lead sponsor	Celularity Incorporated
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	14 April 2022
Primary completion	15 February 2024
Estimated completion	15 February 2024
Sites	3 locations across United States

Drugs / interventions tested

• CYNK-101
• Pembrolizumab (pembrolizumab) — full drug profile →
• Trastuzumab (trastuzumab) — full drug profile →
• Recombinant Human Interleukin-2 — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Mesna

Conditions studied

• Metastatic HER2 Positive Gastroesophageal Junction Cancer — all drugs for Metastatic HER2 Positive Gastroesophageal Junction Cancer →

Sponsor

Celularity Incorporated — full company profile →

Who can join

Adults 18 to 75, any sex, with Metastatic HER2 Positive Gastroesophageal Junction Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will find the maximum tolerated dose (MTD) of CYNK-101 which contains Natural Killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-101 will be administered as first-line treatment, following induction therapy consisting of Pembrolizumab, Trastuzumab and a Fluoropyrimidine / Platinum based Chemotherapy regimen. Patients are required to undergo a biopsy for confirmation of HER2 positivity defined as either IHC 3+ or IHC 2+ with a positive fluorescent in-situ hybridization (FISH) or FISH + alone. The safety of this treatment will be evaluated, and researchers will want to learn if NK cells will help in treating patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gastric cancer immunosuppressive microenvironment heterogeneity: implications for therapy development.
   Yasuda T, Wang YA. · · 2024 · cited 139× · PMID 38600020 · DOI 10.1016/j.trecan.2024.03.008
2. Natural Killer Cell Engagers (NKCEs): a new frontier in cancer immunotherapy.
   Zhang M, Lam KP, Xu S. · · 2023 · cited 41× · PMID 37638058 · DOI 10.3389/fimmu.2023.1207276
3. HER2-Positive Gastric Cancer and Antibody Treatment: State of the Art and Future Developments.
   Scheck MK, Hofheinz RD, Lorenzen S. · · 2024 · cited 28× · PMID 38611014 · DOI 10.3390/cancers16071336
4. Micro Immune Response On-chip (MIRO) models the tumour-stroma interface for immunotherapy testing.
   Perucca A, Llonín AG, Benach OM, Hallopeau C, et al · · 2025 · cited 17× · PMID 39900918 · DOI 10.1038/s41467-025-56275-1
5. Therapeutic approaches to enhance natural killer cell cytotoxicity.
   Stenger TD, Miller JS. · · 2024 · cited 14× · PMID 38545115 · DOI 10.3389/fimmu.2024.1356666
6. Gastric Cancer and the Immune System: The Key to Improving Outcomes?
   Keshavjee SH, Moy RH, Reiner SL, Ryeom SW, et al · · 2022 · cited 12× · PMID 36497422 · DOI 10.3390/cancers14235940
7. 'Off the shelf' immunotherapies: Generation and application of pluripotent stem cell-derived immune cells.
   Wang C, Liu J, Li W. · · 2023 · cited 10× · PMID 36855955 · DOI 10.1111/cpr.13425
8. Molecular Mechanism for Malignant Progression of Gastric Cancer Within the Tumor Microenvironment.
   Matsuoka T, Yashiro M. · · 2024 · cited 9× · PMID 39519285 · DOI 10.3390/ijms252111735