NCT05620732 Treatment of Advanced Malignant Solid Tumors With Claudin18.2CAR-T
| NCT ID | NCT05620732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shenzhen University General Hospital |
| Condition | Advanced Pancreatic Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2022-10-01 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2022-10-01 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Li Yu, Dr
PRINCIPAL INVESTIGATOR
Shenzhen University General Hospital
Frequently Asked Questions
Who can join the NCT05620732 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Advanced Pancreatic Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05620732 currently recruiting?
Yes, NCT05620732 is actively recruiting participants. Contact the research team at liyu@vip.163.com for enrollment information.
Where is the NCT05620732 trial being conducted?
This trial is being conducted at Shenzhen, China.
Who is sponsoring the NCT05620732 clinical trial?
NCT05620732 is sponsored by Shenzhen University General Hospital. The principal investigator is Li Yu, Dr at Shenzhen University General Hospital. The trial plans to enroll 20 participants.