Background. We are developing cancer immunotherapy based on the use of autologous tumor tissue that has been rendered replication-incompetent but maintains phenotype and metabolic activity post-preparation. Aim. The aim of this study was to evaluate safety and tolerance to injection of the inactivated tumor cell and adjuvant preparation (Innocell™) within 24 hours of administration in a pilot study in canine patients with solid organ tumors. Methodology. Three canine patients demonstrating accessible solid organ tumors of various types were assessed in this study. The local site injection was monitored post-treatment. Clinical signs of adverse reactions were monitored for 24 hours post-treatment. Blood samples were taken pre-treatment and at 8 and 24 hours post-treatment for all subjects. One subject provided samples at 7 days post-treatment. All blood samples were analyzed for cytokine content for both immune system-associated and tumor-associated cytokines. Results. No signs of adverse reactions at the site of injection or systemically were observed in the study period. A slight fever and lethargy were reported in one subject by the owner post-vaccination. Immune system-associated cytokine levels in two of the three animals were elevated post-treatment. Tumor-associated cytokine levels in all three subjects declined post-treatment from baseline levels with the effect most prominent in the subject with a non-excised tumor. Conclusion. Subcutaneous injection of the inactivated tumor cells and adjuvant was well tolerated in this pilot study. Cytokine responses observed were in line with the intended use of the treatment in stimulating immune response without adverse clinical observations. Additional evaluation is warranted.

中文翻译：

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Innocell™ 癌症免疫疗法在犬类受试者中的初步急性安全性评估

背景。我们正在开发基于使用自体肿瘤组织的癌症免疫疗法，该肿瘤组织已被复制无能力，但在制备后保持表型和代谢活性。瞄准。本研究的目的是在患有实体器官肿瘤的犬类患者的初步研究中评估在给药后 24 小时内注射灭活肿瘤细胞和辅助制剂 (Innocell™) 的安全性和耐受性。方法. 在这项研究中评估了三名表现出各种类型的可接近实体器官肿瘤的犬类患者。在治疗后监测局部部位注射。治疗后24小时监测不良反应的临床症状。对所有受试者在治疗前和治疗后 8 和 24 小时采集血样。一名受试者在治疗后 7 天提供样品。分析所有血液样本中免疫系统相关和肿瘤相关细胞因子的细胞因子含量。结果. 在研究期间未观察到注射部位或全身性不良反应的迹象。接种疫苗后，所有者报告一名受试者出现轻微发烧和嗜睡。三只动物中有两只的免疫系统相关细胞因子水平在治疗后升高。所有三名受试者的肿瘤相关细胞因子水平在治疗后均从基线水平下降，在未切除肿瘤的受试者中效果最为显着。结论。在这项初步研究中，皮下注射灭活的肿瘤细胞和佐剂具有良好的耐受性。观察到的细胞因子反应与治疗在刺激免疫反应方面的预期用途一致，没有不良的临床观察。有必要进行额外评估。