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Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T | Clinical Trials | Clareo Health

RECRUITINGNA

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

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

NCT05620732•Shenzhen University General Hospital

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+1 more criteria

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;
+7 more criteria

Locations (1)

Li Yu

Shenzhen, Guangdong, China

Key Dates

Start Date

October 1, 2022

Primary Completion Date

October 31, 2025

Completion Date

October 31, 2028

Last Updated

November 22, 2022

Enrollment

ESTIMATED participants

Conditions

Advanced Pancreatic CarcinomaAdvanced Gastric Carcinoma

Interventions

Claudin18.2 CAR-T cells

BIOLOGICAL

Contacts

Li Yu, Dr

CONTACT

+8675521839178 liyu@vip.163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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