Stereotactic body radiation therapy plus adoptive vNKT cell therapy for pancreatic cancer: protocol of a phase II trial.

IF 2.7 4区医学 Q3 IMMUNOLOGY

Immunotherapy Pub Date : 2025-07-16 DOI:10.1080/1750743X.2025.2533112

Xiaofei Zhu, Xiaolan Yin, Wenyu Liu, Chunshan Yu, Sheng Xia, Yangsen Cao, Lingong Jiang, Zhenhong Guo, Minghui Zhang, Huojun Zhang

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引用次数: 0

Abstract

Aims: Novel and multimodal immunotherapy approaches are required for pancreatic cancer. A novel subset of NKT cells, called CD8+ NKT-like cells or variant NKT (vNKT) cells, which are CD8⁺ CD56⁺, CD1d-independent with variant TCR, have been reported to provide potent anti-tumor immunity. With positive immune regulations of stereotactic body radiation therapy (SBRT) reported in previous studies, we hypothesize that there might be a synergy of SBRT with immunotherapy. The aim of this study is to evaluate the efficacy and safety of SBRT plus vNKT cells as adoptive cell therapy for advanced pancreatic cancer.

Methods: The prescription dose of SBRT ranges from 35 to 40 Gy/5f. Transfer of allogeneic vNKT cells is initiated 1-2 weeks after SBRT. Patients receive transfusion of vNKT cells twice a month with a 12-24 h interval within 6 months after SBRT and once a month thereafter. A 12-month transfer is defined as a cycle. The primary outcome is overall survival. The secondary outcomes are progression-free survival, adverse events, and quality of life.

Conclusion: Therapeutic potential of SBRT plus vNKT cells may provide a novel insight into the treatment for advanced pancreatic cancer, and further investigations on the clinical benefits compared to standard chemoradiotherapy are warranted.

Clinical trial registration: www.clinicaltrials.gov identifier is NCT05783076.

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胰腺癌立体定向放射治疗加过继性vNKT细胞治疗：II期试验方案。

目的：胰腺癌需要新的和多模式的免疫治疗方法。据报道，一种新的NKT细胞亚群，称为CD8+ NKT样细胞或变体NKT （vNKT）细胞，具有CD8+ CD56+， cd1 -不依赖于变体TCR，可提供有效的抗肿瘤免疫。鉴于已有研究报道立体定向体放射治疗（SBRT）具有积极的免疫调节作用，我们推测SBRT与免疫治疗可能存在协同作用。本研究的目的是评估SBRT + vNKT细胞作为晚期胰腺癌过继细胞治疗的有效性和安全性。方法：SBRT处方剂量为35 ~ 40 Gy/5f。同种异体vNKT细胞在SBRT后1-2周开始转移。患者在SBRT后6个月内每月输注两次vNKT细胞，间隔12-24小时，此后每月输注一次。12个月的调动被定义为一个周期。主要终点是总生存期。次要结局是无进展生存期、不良事件和生活质量。结论：SBRT + vNKT细胞的治疗潜力可能为晚期胰腺癌的治疗提供新的见解，与标准放化疗相比，进一步的临床益处研究是有必要的。临床试验注册：www.clinicaltrials.gov标识符：NCT05783076。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Immunotherapy 医学-免疫学

CiteScore

5.00

自引率

3.60%

发文量

113

审稿时长

6-12 weeks

期刊介绍： Many aspects of the immune system and mechanisms of immunomodulatory therapies remain to be elucidated in order to exploit fully the emerging opportunities. Those involved in the research and clinical applications of immunotherapy are challenged by the huge and intricate volumes of knowledge arising from this fast-evolving field. The journal Immunotherapy offers the scientific community an interdisciplinary forum, providing them with information on the most recent advances of various aspects of immunotherapies, in a concise format to aid navigation of this complex field. Immunotherapy delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for this vitally important area of research. Unsolicited article proposals are welcomed and authors are required to comply fully with the journal''s Disclosure & Conflict of Interest Policy as well as major publishing guidelines, including ICMJE and GPP3.