NCT06782425

Treating Claudin18.2-positive Advanced Solid Tumors with XKDCT225(Targeting Claudin18.2-CAR-T)

A Single-center, Single-arm, Dose-escalation Exploratory Clinical Trial of the Safety, Efficacy, and Pharmacokinetics of XKDCT225 (Targeting Claudin18.2-CAR-T) Cell Injectionin Claudin18.2-positive Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Shenzhen Celconta Life Science Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT225 cell injection in Claudin18.2-positive advanced solid tumors

Detailed description

This study is a prospective, single-arm, open-label, single-dose dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor efficacy characteristics of XKDCT225 cell injection preparation in subjects with Claudin18.2-positive advanced solid tumors. The study will enroll subjects with pathologically confirmed advanced solid tumors, positive Claudin18.2 expression, who have previously received standard treatment, failed treatment or cannot tolerate it. Imaging examinations show evaluable tumor lesions. This study adopts a single-arm, single-center, dose-escalation design, and uses "accelerated titration" and "3+3" trial designs for dose escalation . It is expected to include 9-18 patients to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of XKDCT225 cell injection . Main purpose: the safety and tolerability of XKDCT225 cell injection in patients with Claudin18.2-positive advanced solid malignancies. Secondary Purpose: the pharmacokinetic and pharmacodynamic characteristics of XKDCT225 cell injection in patients with Claudin18.2-positive advanced solid malignancies; To preliminarily evaluate the efficacy of XKDCT225 cell injection in patients with Claudin18.2-positive advanced solid malignancies.

Conditions

• Claudin18.2 Positive Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	XKDCT225	Autologous targeted claudin18.2 chimeric antigen receptor T cell injection

Timeline

• Start date: 2025-01-01
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-01-17
• Last updated: 2025-01-17

Locations

1 site across 1 country: China