NCT05952375

Exploratory Clinical Trial on the Safety, Efficacy, and Pharmacokinetics of XKDCT086 (iPD-1-Claudin18.2-CAR-T) in Claudin 18.2 Positive Advanced Solid Malignant Tumors: a Single Center, Single Arm, Dose-increasing Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: The Affiliated Hospital of Qingdao University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assessing the safety and tolerability of XKDCT086 cells against recurrent or refractory solid tumors with Claudin18.2 positivity.This experiment proposes to enroll 9-18 patients, the experimental drug is a chimeric antigen receptor T cell preparation targeting Claudin18.2.

Detailed description

This study adopts a single arm, single center, and dose increasing design, using a "3+3" design for dose increasing to evaluate the safety, tolerance, and effectiveness of XKDCT086 cells, as well as to evaluate the pharmacokinetic characteristics of XKDCT086 cells, the correlation between cytokines and efficacy, and immunogenicity. The experimental process of this study is divided into seven stages: screening period, blood collection period, baseline period, clearance period, study treatment and safety observation period after treatment, follow-up period, and long-term follow-up.

Conditions

• Gastric Cancer

Interventions

Type	Name	Description
DRUG	Chimeric antigen receptor T cell preparation targeting Claudin18.2	Chimeric antigen receptor T cell preparation targeting Claudin18.2

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-02-28
• Completion: 2025-02-28
• First posted: 2023-07-19
• Last updated: 2023-07-19

Locations

1 site across 1 country: China