肿瘤细胞治疗研究
英文原题：Investigator Initiated Study to Assess the Safety of Combination of CLS-015 With Anti-CD-19 CAR-T Cells in Patients With Stable/Progressive Large B Cell Lymphoma at Lymphodepletion.
这是一项 I 期注册临床试验，评估细胞治疗用于大 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 12 例。试验地点：其他 · 特拉维夫（共 1 个中心）。登记号：NCT07361224。
不限性别 · ≥ 18 Years
纳入标准： • 签署知情同意时年龄≥18岁。 • 大B细胞淋巴瘤，接受过靶向CD19的CAR-T治疗（tisagenlecleucel、axicabtagene ciloleucel或lisocabtagene maraleucel）。 • 淋巴细胞清除治疗当日经PET-CT确认疾病稳定或进展。 • 能够签署知情同意。 • 东部肿瘤协作组（ECOG）体能状态评分0–2。 排除标准： • 对CLS-015过敏。 • 研究者认为会危及受试者安全，或干扰研究评估、程序或完成的任何有临床意义的状况、疾病或异常。 • 存在需要抗生素治疗的活动性感染。 • 女性妊娠或哺乳。
Inclusion Criteria: * Participant must be at least 18 years of age inclusive, at the time of signing the informed consent. * Large B-Cell lymphoma treated with CAR-T targeting CD19 (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) * Stable Disease or Progressive Disease confirmed by PET-CT on the day of lymphodepletion * Capable of giving signed informed consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 Exclusion Criteria: * Hypersensitivity to CLS-015 * Evidence of any clinically significant condition, disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluation, procedures or completion. * Active infection requiring antibiotics * Females only: Pregnant or breastfeeding
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：To evaluate the safety and tolerability of CLS-015 in combination with anti CD19 CAR T therapy in subjects with stable/progressive Large B-Cell lymphoma at lymphodepletion when CLS-015 is given in adjuvant setting. · Safety and tolerability of CLS-015 based on adverse events evaluation and recording will be evaluated from screening to the end of study. · Through study completion, an average of 2 years.
在CAR-T输注后第0、3、6、10和15天输注CLS-015。
这是一项单中心、开放标签I期研究，评估CLS-015联合抗CD19 CAR-T治疗大B细胞淋巴瘤患者的安全性。研究旨在通过逆转中性粒细胞胞外诱捕网（NET）对免疫功能和CAR-T细胞的负面影响，改善临床反应。
This is a Phase 1, single-center, open-label study to evaluate the safety of CLS-015 in combination with anti-CD19 CAR-T therapy in patients with large B-cell lymphoma. The goal is to improve clinical response by reversing the negative effects of NETs on immune function and CAR-T cells.
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