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

November 17, 2022 updated by: YuLi, Shenzhen University General Hospital

Efficacy and Safety of Claudin18.2CAR-T in Advanced Pancreatic Cancer and Gastric Carcinoma

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Li Yu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 18-75 (≥ 18, ≤ 75), regardless of gender;
  2. Subjects voluntarily participate in the study, and they or their legal guardians sign the Informed Consent Form;
  3. 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);
  4. According to RECIST 1.1 standard, there are clearly measurable and evaluable lesions;
  5. Immunohistochemical staining confirmed that Claudin 18.2 was moderately and highly expressed in tumor tissues;
  6. Subjects must have received the first and second line standard treatment scheme;
  7. 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
  8. Within 2 weeks before cell therapy, no antibody drugs were used;
  9. ECOG score is 0-2;
  10. The subjects had no contraindication for peripheral blood collection;
  11. The expected survival period is more than 3 months.

Exclusion Criteria:

  1. People who have a history of allergy to any component in cell products;
  2. 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 ；
  3. 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;
  4. 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;
  5. Pulmonary function is abnormal, and the saturation of blood oxygen under indoor air is less than 92%;
  6. Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other serious heart diseases clinically within 12 months before enrollment;
  7. Grade 3 hypertension and poor blood pressure control after drug treatment;
  8. Have suffered from brain trauma, consciousness disorder, epilepsy, relatively serious cerebral ischemia or cerebral hemorrhage disease in the past;
  9. Patients with autoimmune diseases, immunodeficiency or other patients requiring immunosuppressive treatment;
  10. There is uncontrolled active infection;
  11. Have used any CAR-T cell product or other genetically modified T cell therapy before;
  12. Live vaccine inoculation within 4 weeks before enrollment;
  13. HIV, HBV, HCV and TPPA/RPR positive persons, and HBV carriers;
  14. Subjects have a history of alcohol abuse, drug abuse or mental illness;
  15. Subjects have participated in any other clinical research within 3 months before joining this clinical research;
  16. 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;
  17. The investigator believes that there are other circumstances that are not suitable for the subject to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Patients treated with Claudin 18.2 CAR-T cells.
Biological: Claudin18.2 CAR-T cells
patients treated with Claudin18.2 CAR-T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE/SAE
Time Frame: From date of infusion to 30 days after infusion
adverse events/ severe adverse events
From date of infusion to 30 days after infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: From admission to the end of follow up, up to 2 years.
overall response rate
From admission to the end of follow up, up to 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen University General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Anticipated)

October 31, 2025

Study Completion (Anticipated)

October 31, 2028

Study Registration Dates

First Submitted

November 11, 2022

First Submitted That Met QC Criteria

November 11, 2022

First Posted (Actual)

November 17, 2022

Study Record Updates

Last Update Posted (Actual)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEM-ONCO-025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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