NCT05875402

XKDCT080 in GCC-positive Recurrent or Refractory Solid Tumors With Single Center, Single Arm, and Dose Escalation

Exploratory Clinical Trial on the Safety, Tolerability, Efficacy, and Pharmacokinetics of XKDCT080 in GCC-positive Recurrent or Refractory Solid Tumors With Single Center, Single Arm, and Dose Escalation

• 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 XKDCT080 cells against recurrent or refractory solid tumors with GCC positivity.This experiment proposes to enroll 9-18 patients, the experimental drug is a chimeric antigen receptor T cell preparation targeting GCC. Secondary purpose of the study 1. Evaluate the pharmacokinetic characteristics of XKDCT080 cells after intravenous infusion into GCC-positive patients with recurrent or refractory solid tumors; 2. Preliminary Evaluation of the Effectiveness of XKDCT080 Cells in Patients with Recurrent or Refractory Solid Tumors Positive for GCC; 3. Explore the relationship between cytokines and therapeutic efficacy in patients with recurrent or refractory solid tumors who are positive for GCC after intravenous infusion of XKDCT080 cells.

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 XKDCT080 cells, as well as to evaluate the pharmacokinetic characteristics of XKDCT080 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

• Colon Cancer

Interventions

Type	Name	Description
DRUG	Chimeric antigen receptor T cell preparation targeting GCC	Chimeric antigen receptor T cell preparation targeting GCC

Timeline

• Start date: 2023-04-01
• Primary completion: 2023-12-28
• Completion: 2025-05-30
• First posted: 2023-05-25
• Last updated: 2023-05-25

Locations

1 site across 1 country: China