迄今为止，由于个人遗传签名的差异、肿瘤微环境的复杂性和表观遗传学致癌机制的影响，规范临床预测免疫治疗生物标志物以评估治疗反应仍具有挑战性。早期监测关键的非编码RNA（ncRNA）生物标志物可能有助于预测癌症免疫治疗的临床疗效，并找出标准的预测性ncRNA生物标志物。例如，在应用抗PD-1治疗的非小细胞肺癌患者血浆中，miR-125b-5p水平降低可以预示积极结果。在接受嵌合抗原受体T淋巴细胞（CAR-T）疗法治疗的结肠直肠癌患者血浆中，miR-153水平可能表明T细胞杀伤活性的激活。miR-148a-3p和miR-375水平可能预测B细胞急性淋巴细胞白血病患者对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预后的预测性生物标志物。因此，迫切需要进一步研究，阐明可能能够预测免疫治疗早期临床反应的关键ncRNA生物标志物。 本综述总结了在被不同免疫治疗方法治疗的癌症患者中报告的重要预测性ncRNA生物标志物，包括单克隆抗体、小分子抑制剂、癌症疫苗和CAR-T细胞。此外，还提供了对未来展望的简要讨论，概述了利用免疫调控性ncRNA生物标志物作为预测工具和治疗靶点的技术方法。 © 2023年作者。由上海临床生物信息学研究所代表John Wiley＆Sons Australia Ltd.发表的《临床与转化医学》公开发表。

To date, standardising 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 immunomodulatory 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.