迄今为止，由于个人遗传特征、肿瘤微环境复杂性和表观遗传肿瘤机制的变化，标准化用于评估免疫治疗反应的临床预测生物标志物仍然具有挑战性。关键非编码 RNA (ncRNA) 生物标志物的早期监测可能有助于预测临床癌症免疫疗法的功效并提出标准的预测性 ncRNA 生物标志物。例如，接受抗 PD-1 治疗的非小细胞肺癌患者血浆中 miR-125b-5p 水平降低预示着积极的结果。接受嵌合抗原受体 T 淋巴细胞 (CAR-T) 细胞疗法治疗的结直肠癌患者血浆中 miR-153 的水平可能表明 T 细胞杀伤活性的激活。 miR-148a-3p 和 miR-375 水平可以预测 B 细胞急性淋巴细胞白血病对 CAR-T 细胞疗法的良好反应。在接受 GPC3 肽疫苗治疗的癌症患者中，miR-1228-5p、miR-193a-5p 和 miR-375-3p 的血清水平被报告为良好反应和改善总体生存率的预测生物标志物。因此，迫切需要进一步研究来详细说明有潜力预测免疫治疗早期临床反应的关键 ncRNA 生物标志物。这篇综述总结了在接受不同免疫治疗方式（包括单克隆抗体）治疗的癌症患者中报告的重要预测性 ncRNA 生物标志物、小分子抑制剂、癌症疫苗和CAR-T细胞。此外，还对即将出现的观点进行了简明讨论，概述了最佳利用免疫调节 ncRNA 生物标志物作为预测工具和治疗靶标的技术方法。© 2023 作者。约翰·威利出版的《临床与转化医学》

To date, standardizing clinical predictive biomarkers for assessing the response to immunotherapy remains challenging due to variations in personal genetic signatures, tumour microenvironment complexities and epigenetic onco-mechanisms.Early monitoring of key non-coding RNA (ncRNA) biomarkers may help in predicting the clinical efficacy of cancer immunotherapy and come up with standard predictive ncRNA biomarkers. For instance, reduced miR-125b-5p level in the plasma of non-small cell lung cancer patients treated with anti-PD-1 predicts a positive outcome. The level of miR-153 in the plasma of colorectal cancer patients treated with chimeric antigen receptor T lymphocyte (CAR-T) cell therapy may indicate the activation of T-cell killing activity. miR-148a-3p and miR-375 levels may forecast favourable responses to CAR-T-cell therapy in B-cell acute lymphoblastic leukaemia. In cancer patients treated with the GPC3 peptide vaccine, serum levels of miR-1228-5p, miR-193a-5p and miR-375-3p were reported as predictive biomarkers of good response and improved overall survival. Therefore, there is a critical need for further studies to elaborate on the key ncRNA biomarkers that have the potential to predict early clinical responses to immunotherapy.This review summarises important predictive ncRNA biomarkers that were reported in cancer patients treated with different immunotherapeutic modalities including monoclonal antibodies, small molecule inhibitors, cancer vaccines and CAR-T cells. In addition, a concise discussion on forthcoming perspectives is provided, outlining technical approaches for the optimal utilisation of immune-modulatory ncRNA biomarkers as predictive tools and therapeutic targets.© 2023 The Authors. Clinical and Translational Medicine published by John Wiley & Sons Australia, Ltd on behalf of Shanghai Institute of Clinical Bioinformatics.