肿瘤细胞治疗研究
英文原题：Role of the Gut Microbiome in the Outcome of Diffuse Large B-Cell Lymphoma Patients Treated With CAR-T Cell Therapy
这是一项分期未标注的注册临床试验，评估细胞治疗用于弥漫大 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 69 例。试验地点：欧洲 · 博洛尼亚（共 1 个中心）。登记号：NCT05725720。
不限性别 · ≥ 18 Years
纳入标准： 1. 年龄≥18岁。 2. 组织学确诊弥漫性大 B 细胞淋巴瘤（DLBCL）。 3. 按获批临床适应证适合接受商业化 CAR-T 细胞治疗。 4. 提供书面知情同意。 排除标准： 1. 存在可能影响依从性或结果解释的显著、未控制合并疾病。 2. 同时患有第二种恶性肿瘤。
Inclusion Criteria: 1. Age ≥18 years. 2. Patients affected by histologically confirmed DLBCL. 3. Patients amenable for CAR-T cell therapy as for clinical approved indication (commercial products). 4. Patients must provide written informed consent. Exclusion Criteria: 1. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results. 2. Concurrent second malignancy.
以上为辅助阅读译文。是否适合入组须由主治医生判断，最终以登记平台与研究者确认为准。
主要终点：Characterization of GM heterogeneity (taxa) in diffuse large B-cell lymphoma patients undergoing CAR-T cell therapy. · Characterization of the compositional and functional modifications of GM in patients affected by lymphoma undergoing therapy with CAR-T cells from baseline until the restaging after 18 months from the CAR-T cell infusion. GM profiling will be achieved by next-generation sequencing approaches, including 16S rRNA gene-based sequencing for diversity and compositional structure, and shotgun metagenomics for species-level and functional insights, including information on eukaryotes and viruses. · 24 months
次要终点：Correlation between GM and CAR-T cell therapy outcomes in terms of response, toxicity and disease control.
尽管部分患者接受 CAR-T 治疗后疗效显著，临床反应仍存在较大差异。近期研究发现，肠道微生物组（GM）可能是癌症预后和治疗反应的重要可调节因素：多样性高、健康相关菌群丰富且致病共生菌较少的微生物组通常与较好疗效和较长生存相关。目前尚不清楚肠道微生物组是否也会调节淋巴瘤患者对 CAR-T 的抗肿瘤反应及相关毒性。
Despite impressive outcomes in selected patients, significant heterogeneity in clinical response to CAR-T cell therapy remains. The gut microbiome (GM) has recently emerged as one of the key modifiable factors of prognosis and response to treatment in cancer patients, with high-diversity profiles rich in health-associated taxa while poor in pathobionts generally associated with better response and longer survival. Currently, it is unknown if GM also modulates anti-tumor responses to CAR-T cells and related toxicities in lymphomas.
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