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

Primary Purpose

Colon Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Chimeric antigen receptor T cell preparation targeting GCC
Sponsored by
The Affiliated Hospital of Qingdao University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Chimeric Antigen

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: To be eligible for the study, patients must meet ALL of the following criteria prior to participation: Age range from 18 to 75 years (including threshold), regardless of gender; Solid tumors with positive expression of guanylate cyclase (GCC) were detected by immunohistochemistry in tumor tissue; Patients with solid tumors who have failed standard treatment, are intolerant to standard treatment, have no standard treatment options, or have relapsed; At least one measurable lesion (non lymph node lesion with a length diameter of ≥ 10mm and lymph node lesion with a short diameter of ≥ 15mm) is required using the RECIST 1.1 standard; ECOG physical condition score 0-2; Blood routine standard: hemoglobin ≥ 90g/L (no blood transfusion within 14 days), neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L; Blood biochemistry should meet the following standards: total bilirubin ≤ 1.5 × ULN (upper limit of normal value), ALT and AST ≤ 2.5 × ULN (excluding patients with liver metastasis); ALT and AST ≤ 5 in patients with liver metastasis × ULN; Serum creatinine ≤ 1 × ULN, glomerular filtration rate>50mL/min (GFR=[(140 age) × weight × (0.85 female)]/(72 × Scr), serum lipase and amylase<1.5 × ULN (upper limit of normal value), albumin ≥ 2.8g/dL; Cardiac ejection fraction>50%; No hemorrhagic diseases or coagulation disorders; The expected survival period is ≥ 12 weeks; The subjects voluntarily participated in the study and signed an informed consent form. Exclusion Criteria: Patients with any of the following criteria will not be allowed to participation: Pregnant or lactating women; Participate in other drug clinical trials within 4 weeks before screening; There are uncontrollable cardiovascular and cerebrovascular diseases within the first 6 months of screening, such as heart failure or others; Have a history of drug abuse and are unable to quit or have a history of mental disorders; Has received any immune cell therapy in the past; Fungi, bacteria, viruses, or other infections that cannot be controlled or require antibiotic treatment; Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, and HBV-DNA>500 IU/mL; Patients with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Syphilis antibody positive individuals; Allergies or intolerance to research drugs such as Tozumab, Fludarabine, Cyclophosphamide, Capecitabine, and other gonorrhea clearing drugs selected by the researchers; Active autoimmune diseases such as systemic lupus erythematosus or others within the first 3 months of screening; Suffering from known symptomatic central nervous system (CNS) diseases; The surgery was performed within 2 weeks before the single collection and the researcher believes that it may affect the safety of patient safety; There was a history of deep vein thrombosis or pulmonary embolism 6 months before enrollment; Used drugs that affect immune function one month before screening; Previously received GCC targeted therapy; According to the judgment of the researcher, patients who are not suitable to participate in this study;

Sites / Locations

  • The Affiliated Hospital of Qingdao UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XKDCT080 treatment for patients with GCC target positivity

Arm Description

Drug: XKDCT080 (chimeric antigen receptor T cell preparation targeting GCC) Dosage form: Cell suspension Dose: 30-50mL/bag Medication method: intravenous drip Frequency: Once

Outcomes

Primary Outcome Measures

Adverse Events (AE)
To characterize the safety profile of XKDCT080 in patients with advanced solid tumor as assessed by incidence of adverse events

Secondary Outcome Measures

Full Information

First Posted
April 25, 2023
Last Updated
May 16, 2023
Sponsor
The Affiliated Hospital of Qingdao University
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1. Study Identification

Unique Protocol Identification Number
NCT05875402
Brief Title
XKDCT080 in GCC-positive Recurrent or Refractory Solid Tumors With Single Center, Single Arm, and Dose Escalation
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 28, 2023 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Hospital of Qingdao University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 Evaluate the pharmacokinetic characteristics of XKDCT080 cells after intravenous infusion into GCC-positive patients with recurrent or refractory solid tumors; Preliminary Evaluation of the Effectiveness of XKDCT080 Cells in Patients with Recurrent or Refractory Solid Tumors Positive for GCC; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Chimeric Antigen

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XKDCT080 treatment for patients with GCC target positivity
Arm Type
Experimental
Arm Description
Drug: XKDCT080 (chimeric antigen receptor T cell preparation targeting GCC) Dosage form: Cell suspension Dose: 30-50mL/bag Medication method: intravenous drip Frequency: Once
Intervention Type
Drug
Intervention Name(s)
Chimeric antigen receptor T cell preparation targeting GCC
Intervention Description
Chimeric antigen receptor T cell preparation targeting GCC
Primary Outcome Measure Information:
Title
Adverse Events (AE)
Description
To characterize the safety profile of XKDCT080 in patients with advanced solid tumor as assessed by incidence of adverse events
Time Frame
12 months]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: To be eligible for the study, patients must meet ALL of the following criteria prior to participation: Age range from 18 to 75 years (including threshold), regardless of gender; Solid tumors with positive expression of guanylate cyclase (GCC) were detected by immunohistochemistry in tumor tissue; Patients with solid tumors who have failed standard treatment, are intolerant to standard treatment, have no standard treatment options, or have relapsed; At least one measurable lesion (non lymph node lesion with a length diameter of ≥ 10mm and lymph node lesion with a short diameter of ≥ 15mm) is required using the RECIST 1.1 standard; ECOG physical condition score 0-2; Blood routine standard: hemoglobin ≥ 90g/L (no blood transfusion within 14 days), neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 80 × 109/L; Blood biochemistry should meet the following standards: total bilirubin ≤ 1.5 × ULN (upper limit of normal value), ALT and AST ≤ 2.5 × ULN (excluding patients with liver metastasis); ALT and AST ≤ 5 in patients with liver metastasis × ULN; Serum creatinine ≤ 1 × ULN, glomerular filtration rate>50mL/min (GFR=[(140 age) × weight × (0.85 female)]/(72 × Scr), serum lipase and amylase<1.5 × ULN (upper limit of normal value), albumin ≥ 2.8g/dL; Cardiac ejection fraction>50%; No hemorrhagic diseases or coagulation disorders; The expected survival period is ≥ 12 weeks; The subjects voluntarily participated in the study and signed an informed consent form. Exclusion Criteria: Patients with any of the following criteria will not be allowed to participation: Pregnant or lactating women; Participate in other drug clinical trials within 4 weeks before screening; There are uncontrollable cardiovascular and cerebrovascular diseases within the first 6 months of screening, such as heart failure or others; Have a history of drug abuse and are unable to quit or have a history of mental disorders; Has received any immune cell therapy in the past; Fungi, bacteria, viruses, or other infections that cannot be controlled or require antibiotic treatment; Hepatitis B surface antigen (HBsAg) positive or hepatitis B core antibody (HBcAb) positive, and HBV-DNA>500 IU/mL; Patients with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Syphilis antibody positive individuals; Allergies or intolerance to research drugs such as Tozumab, Fludarabine, Cyclophosphamide, Capecitabine, and other gonorrhea clearing drugs selected by the researchers; Active autoimmune diseases such as systemic lupus erythematosus or others within the first 3 months of screening; Suffering from known symptomatic central nervous system (CNS) diseases; The surgery was performed within 2 weeks before the single collection and the researcher believes that it may affect the safety of patient safety; There was a history of deep vein thrombosis or pulmonary embolism 6 months before enrollment; Used drugs that affect immune function one month before screening; Previously received GCC targeted therapy; According to the judgment of the researcher, patients who are not suitable to participate in this study;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jing wang, MD
Phone
18661805686
Email
wangstella5@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jing wang, MD
Organizational Affiliation
The Affiliated Hospital of Qingdao University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Affiliated Hospital of Qingdao University
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jing wang
Phone
18661805686
Email
wangstella5@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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