NCT06464965

Clinical Study of Cord Blood-Derived CAR-NK Cells in Gastric Cancer and Pancreatic Cancer

A Phase I Clinical Study of Cord Blood-Derived CAR-NK Cells Targeting Claudin18.2 in the Treatment of Advanced Gastric Cancer and Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Zhejiang Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Main Objective: To study the maximum tolerated dose (MTD) and dose-dependent toxicity (DLT) of cord blood-derived CAR-NK cells (CB CAR-NK182) targeting Claudin18.2 in patients with advanced gastric cancer and advanced pancreatic cancer. Secondary Objective: To evaluate the efficacy of CB CAR-NK182 in patients with advanced gastric cancer and advanced pancreatic cancer: overall objective tumor response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), etc. To evaluate the CAR-NK amplification and persistence of CB CAR-NK182 in the blood of patients with advanced gastric cancer and advanced pancreatic cancer;

Conditions

• Gastric Cancer
• Pancreas Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	CB CAR-NK18.2	Administered via intravenous infusion on Days 0, 3, and 7. Three dose levels are planned: Dose Level 1: 2×10\^6 cells/kg/infusion Dose Level 2: 8×10\^6 cells/kg/infusion Dose Level 3: 16×10\^6 cells/kg/infusion
DRUG	Cyclophosphamide	Part of the lymphodepletion regimen. Administered at 500 mg/m\^2/day on Days -5 to -3 prior to the first CAR-NK cell infusion.
DRUG	Fludarabine	Part of the lymphodepletion regimen. Administered at 30 mg/m\^2/day on Days -5 to -3 prior to the first CAR-NK cell infusion.

Timeline

• Start date: 2024-07-03
• Primary completion: 2025-10-10
• Completion: 2025-12-30
• First posted: 2024-06-18
• Last updated: 2026-04-16

Locations

1 site across 1 country: China