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Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T

Primary Purpose

Advanced Pancreatic Carcinoma, Advanced Gastric Carcinoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Claudin18.2 CAR-T cells
Sponsored by
Shenzhen University General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Pancreatic Carcinoma

Eligibility Criteria

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

Inclusion Criteria: Age 18-75 (≥ 18, ≤ 75), regardless of gender; Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form; Non resectable, locally late recurrent or metastatic gastric cancer or pancreatic cancer confirmed by histopathology; Patients with gastric cancer or pancreatic cancer diagnosed as stage III or IV according to the TNM staging system of the American Joint Commission on Cancer (AJCC) (8th edition in 2017); According to RECIST 1.1 standard, there are clearly measurable and evaluable lesions; Immunohistochemical staining confirmed that Claudin 18.2 was moderately and highly expressed in tumor tissues; Subjects must have received the first and second line standard treatment scheme; The subject must not be suitable for receiving radical treatment methods, such as radical chemotherapy and radiotherapy and/or surgery/immunosuppressant at the checkpoint, or refuse surgical resection Within 2 weeks before cell therapy, no antibody drugs were used; ECOG score is 0-2; The subjects had no contraindication for peripheral blood collection; The expected survival period is more than 3 months. Exclusion Criteria: People who have a history of allergy to any component in cell products; The following conditions occur in blood routine examination: WBC ≤ 1 × 109/L, absolute value of central granulocyte ANC ≤ 0.5 × 109/L, absolute value of lymphocyte ALC ≤ 0.5 × 109/L , PLT≦25 × 109/L ; The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg/dl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg/dl; According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)<50% by echocardiography; Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%; Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment; Grade 3 hypertension and poor blood pressure control after drug treatment; Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past; Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment; There is uncontrolled active infection; Have used any CAR-T cell product or other genetically modified T cell therapy before; Live vaccine inoculation within 4 weeks before enrollment; HIV, HBV, HCV and TPPA/RPR positive persons, and HBV carriers; Subjects have a history of alcohol abuse, drug abuse or mental illness; Subjects have participated in any other clinical research within 3 months before joining this clinical research; Female subjects have any of the following conditions: a) are in pregnancy/lactation; Or b) having a pregnancy plan during the trial; Or c) is fertile and unable to take effective contraceptive measures; The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study

Sites / Locations

  • Li YuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment group

Arm Description

Patients treated with Claudin 18.2 CAR-T cells.

Outcomes

Primary Outcome Measures

AE/SAE
adverse events/ severe adverse events

Secondary Outcome Measures

ORR
overall response rate

Full Information

First Posted
November 11, 2022
Last Updated
November 17, 2022
Sponsor
Shenzhen University General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05620732
Brief Title
Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T
Official Title
Efficacy and Safety of Claudin18.2CAR-T in Advanced Pancreatic Cancer and Gastric Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shenzhen University General Hospital

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 efficacy of advanced pancreatic cancer and gastric cancer needs to be further improved. Claudin is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in gastric cancer and pancreatic cancer. Preclinical studies suggest that Claudin18.2CAR-T can effectively improve the remission rate of patients with advanced solid tumors.
Detailed Description
The efficacy of advanced pancreatic cancer and gastric cancer needs to be further improved. Claudin is a kind of integrin membrane protein in the tight junction between epithelium and endothelium, which is highly expressed in gastric cancer and pancreatic cancer. Preclinical studies suggest that Claudin18.2CAR-T can effectively improve the remission rate of patients with advanced solid tumors. Investigators aim to testify to the safety and efficacy of Claudin18.2CAR-T cells in advanced pancreatic cancer and gastric cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Pancreatic Carcinoma, Advanced Gastric Carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Patients treated with Claudin 18.2 CAR-T cells.
Intervention Type
Biological
Intervention Name(s)
Claudin18.2 CAR-T cells
Intervention Description
patients treated with Claudin18.2 CAR-T cells
Primary Outcome Measure Information:
Title
AE/SAE
Description
adverse events/ severe adverse events
Time Frame
From date of infusion to 30 days after infusion
Secondary Outcome Measure Information:
Title
ORR
Description
overall response rate
Time Frame
From admission to the end of follow up, up to 2 years.

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: Age 18-75 (≥ 18, ≤ 75), regardless of gender; Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form; Non resectable, locally late recurrent or metastatic gastric cancer or pancreatic cancer confirmed by histopathology; Patients with gastric cancer or pancreatic cancer diagnosed as stage III or IV according to the TNM staging system of the American Joint Commission on Cancer (AJCC) (8th edition in 2017); According to RECIST 1.1 standard, there are clearly measurable and evaluable lesions; Immunohistochemical staining confirmed that Claudin 18.2 was moderately and highly expressed in tumor tissues; Subjects must have received the first and second line standard treatment scheme; The subject must not be suitable for receiving radical treatment methods, such as radical chemotherapy and radiotherapy and/or surgery/immunosuppressant at the checkpoint, or refuse surgical resection Within 2 weeks before cell therapy, no antibody drugs were used; ECOG score is 0-2; The subjects had no contraindication for peripheral blood collection; The expected survival period is more than 3 months. Exclusion Criteria: People who have a history of allergy to any component in cell products; The following conditions occur in blood routine examination: WBC ≤ 1 × 109/L, absolute value of central granulocyte ANC ≤ 0.5 × 109/L, absolute value of lymphocyte ALC ≤ 0.5 × 109/L , PLT≦25 × 109/L ; The following conditions occur in laboratory testing: including but not limited to, total serum bilirubin ≥ 1.5mg/dl; Serum ALT or AST is more than 2.5 times of the upper limit of normal; Blood creatinine ≥ 2.0mg/dl; According to the NYHA cardiac function grading standard, patients with cardiac insufficiency belong to Grade III or IV; Or left ventricular ejection fraction (LVEF)<50% by echocardiography; Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%; Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment; Grade 3 hypertension and poor blood pressure control after drug treatment; Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past; Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment; There is uncontrolled active infection; Have used any CAR-T cell product or other genetically modified T cell therapy before; Live vaccine inoculation within 4 weeks before enrollment; HIV, HBV, HCV and TPPA/RPR positive persons, and HBV carriers; Subjects have a history of alcohol abuse, drug abuse or mental illness; Subjects have participated in any other clinical research within 3 months before joining this clinical research; Female subjects have any of the following conditions: a) are in pregnancy/lactation; Or b) having a pregnancy plan during the trial; Or c) is fertile and unable to take effective contraceptive measures; The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yu, Dr
Phone
+8675521839178
Email
liyu@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yu, Dr
Organizational Affiliation
Shenzhen University General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Li Yu
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yu
Phone
+8675521839178
Email
liyu_gcp@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T

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