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COMPLETED
NCT06464965
PHASE1

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

Sponsor: Zhejiang Provincial People's Hospital

View on ClinicalTrials.gov

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;

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2024-07-03

Completion Date

2025-12-30

Last Updated

2026-07-09

Healthy Volunteers

No

Interventions

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.

Locations (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China