Combinational Cell Therapy using Natural Killer Cells and Erbitux in Patients with Advanced Gastric Adenocarcinoma

Early Phase 1

Recruiting

• Conditions: Gastric Adenocarcinoma.; C16. 9 Malignant neoplasm: Stomach, unspecified; C16. 9

• Registration Number: IRCT20140818018842N36
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Age between 20 and 60 years- Histologically confirmed adenocarcinoma of the stomach- Patients who have relapsed at least once after gastrectomy and did not respond to chemotherapy.- Patients receiving the same chemotherapy regimen.- Patients with the same tumor size.- Diffuse form of histopathology.- Eastern Cooperative Oncology Group (ECOG) performance status<2- Life expectancy of at least 3 months- Absence of heart problems- Proper functioning of vital organs:leukocyte count =3000/mm3neutrophil count =1500/mm3platelet count =100,000/mm3hemoglobin =9.0 g/dLserum aspartate aminotransferase (AST) =100 IU/Lalanine aminotransferase (ALT) =100 IU/Lserum total bilirubin =2 mg/dLserum creatinine =1.5 mg/dLblood urea =25 mg/d

Exclusion Criteria

- Positive test for HIV, HTLV-1, syphilis, hepatitis B and C infections- Severe active infection- Serious complications such as diabetes mellitus, unstable angina, or myocardial infarction within 3 months- Pregnancy or lactation period- History of autoimmune diseases and hypersensitivity- History of receiving any type of cell therapy in the last 6 months

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Checking the safety and toxicity of the injected cells. Timepoint: 28 days. Method of measurement: Any side effects related to cell injection will be checked and recorded during the injection and up to 28 days after the injection.If a complication is seen during or after the infusion, the following actions will be taken based on the CTCAE guideline:In grade 1, only the infusion is stopped.In grades 2 and 3, the infusion is stopped along with anti-allergic treatments, including corticosteroids and antihistamines.In grade 4, in addition to the above, resuscitation measures and care in the ICU department are also recommended.