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

A Phase I/IIa Open Label, Non-Randomized, Multicenter Study of CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Aenocarcinoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Celularity Incorporated · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metastatic HER2 Positive Gastroesophageal Junction Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CYNK-101	CYNK-101 is a human placental hematopoietic stem/progenitor cell derived NK cell product, that is genetically modified to express a variant of CD16, Fc gamma receptor III (FcγRIII).
DRUG	Pembrolizumab	200 mg on Day 1 of each 3-week cycle as an IV infusion.
DRUG	Trastuzumab	8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.
DRUG	Recombinant Human Interleukin-2	6 million (M) international units (IU) of rhIL-2 administered subcutaneously (SC) on each CYNK-101 infusion day.
DRUG	Cyclophosphamide	Cyclophosphamide: 900 mg/m2 administered IV as part of a 3-day lymphodepletion regimen.
DRUG	Fludarabine	Fludarabine: 30 mg/m2 administered IV as part of a 3-day lymphodepletion regimen.
DRUG	Mesna	MESNA: shall be administered as part of a 3-day lymphodepletion regimen for the inhibition of hemorrhagic cystitis induced by cyclophosphamide. Route of administration, dosage, and frequency of Mesna should be based on institutional standards.

Timeline

• Start date: 2022-04-14
• Primary completion: 2024-02-15
• Completion: 2024-02-15
• First posted: 2022-01-26
• Last updated: 2024-12-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study