Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-01-07 @ 5:21 AM
Study NCT ID:
NCT05875402
Status:
UNKNOWN
Last Update Posted:
2023-05-25
First Post:
2023-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
XKDCT080 in GCC-positive Recurrent or Refractory Solid Tumors With Single Center, Single Arm, and Dose Escalation
Sponsor:
The Affiliated Hospital of Qingdao University
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: