Treatment for advanced pancreatic and gastric cancers using Claudin18.2 CAR-T cells

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

This study tests a new CAR-T cell treatment for people with advanced pancreatic and gastric cancers to see if it can help them after other treatments have not worked.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Shenzhen University General Hospital (Academic / other)
• Drugs / interventions: CAR-T, chemotherapy
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT05620732 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of Claudin18.2 CAR-T cell therapy in patients with advanced pancreatic and gastric cancers. Claudin18.2 is a protein that is highly expressed in these types of tumors, and preclinical studies suggest that targeting it with CAR-T cells may improve remission rates. Participants will receive Claudin18.2 CAR-T cells after failing standard treatment options. The study aims to provide a new therapeutic approach for patients with non-resectable, late-stage cancers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with non-resectable, locally advanced or metastatic gastric or pancreatic cancer that expresses Claudin18.2.

Not a fit: Patients who have not undergone standard treatment or those with resectable tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve remission rates for patients with advanced pancreatic and gastric cancers.

How similar studies have performed: Preclinical studies have shown promise for similar CAR-T approaches, but this specific application is novel.

Eligibility criteria

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

Where this trial is running

Shenzhen, Guangdong

• Li Yu — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Li Yu, Dr — Shenzhen University General Hospital
• Study coordinator: Li Yu, Dr

Conditions Advanced Pancreatic Carcinoma; Advanced Gastric Carcinoma