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
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.
Timeline
- Start
- 2022-04-14
- Primary completion
- 2024-02-15
- Completion
- 2024-02-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CYNK-101 | Cell therapy | — | — |
| Background | 2-MERCAPTOETHANESULFONIC ACID | Small molecule | — | — |
| Background | Cyclophosphamide | Other / unclassified | 900 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Recombinant Human Interleukin-2 | Protein / enzyme biologic | 6e+06 iu | Subcutaneous |
| Background | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |