Adjuvant Immunotherapy With Dendritic Cells Loaded With Recombinant Chimeric Antigen Mrna In Patient With Metastatic Gastric Cancer; A Clinical Trial

Introduction: Gastric cancer is one of the most common malignancies worldwide. In Iran, it is the second most prevalent cancer and the leading cause of cancer-related deaths. Tumor-associated antigens, including cancer-testis antigens, are a group of proteins typically expressed in cancer cells. Due to changes in the expression of these antigens in tumor tissues, they have emerged as potential targets for cancer immunotherapy and are therefore essential for the development of targeted treatments. Dendritic cell (DC) vaccines are considered a novel approach in cancer immunotherapy, offering the potential for specific activation of the immune system against tumors. However, only a limited number of DC vaccines based on neoantigens have been evaluated in clinical trials. In this study, the therapeutic effect of immunogene therapy using a DC vaccine loaded with mRNA of a recombinant chimeric antigen was assessed in a patient with gastric cancer. Methods: In the preclinical phase, monocytes were collected via leukapheresis and cultured to differentiate into immature dendritic cells (DCs). These cells were then electroporated with mRNA encoding a recombinant chimeric antigen. Subsequently, mature DCs were generated, and cytotoxicity tests were conducted during this phase. In the clinical trial phase, a patient with metastatic gastric adenocarcinoma involving the liver, bone, and ovaries, with recurrence, was selected for this treatment. Based on the preclinical protocols, the patient’s cells were cultured in a Class B clean room. The vaccine was administered in nine doses after confirming successful differentiation and ensuring the absence of bacterial, fungal, and endotoxin contamination.