肿瘤细胞治疗研究
英文原题：A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
这是一项 II 期注册临床试验，评估细胞治疗用于急性淋巴细胞白血病、B 细胞淋巴瘤、非霍奇金淋巴瘤的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 62 例。试验地点：美国 · 哈肯萨克、纽约（共 2 个中心）。登记号：NCT04148430。
不限性别 · ≥ 18 Years
纳入标准： • 年龄≥18岁，确诊复发性CD19阳性B细胞急性淋巴细胞白血病（ALL）、套细胞淋巴瘤（MCL）或非霍奇金淋巴瘤（NHL），并接受已获批上市的CD19特异性CAR-T细胞治疗（如tisagenlecleucel、axicabtagene、brexucabtagene autoleucel等）。 排除标准： • 未控制的全身性真菌或细菌感染。 • 已知对大肠杆菌来源蛋白过敏。 • 有生育可能的女性妊娠检测（血清或尿液）须为阴性；已接受手术绝育或绝经至少2年的女性不视为有生育可能。 • 妊娠或哺乳期女性。
Inclusion Criteria: * Patients (age \>/= 18) with a diagnosis of relapsed CD19+ B-cell ALL, MCL, or NHL receiving commercially approved CD19-specific CAR T cells (e.g. tisagenleuleucel, axicabtagene, brexucabtagene autoleucel, etc) are eligible for the study Exclusion Criteria: * Patients with uncontrolled systemic fungal and bacterial infections * Patients with known hypersensitivity to E. coli-derived proteins * Women of childbearing potential must have a negative serum or urine pregnancy test (women who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential) * Women who are 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：Arm 1 (CAR T Cell Group) Rate of Severe Neurotoxicities · Determine the rate of severe neurotoxicities, \>/= Grade 3 or any grade seizure, within the first 4 weeks of treatment with prophylactic use of anakinra in participants receiving CD19-specific CAR T cells · 4 weeks；Arm 2 (COVID-19 Group) proportion of patients able to avoid death or mechanical ventilation · proportion of patients able to avoid death or mechanical ventilation within 28 days from the start of the treatment. · 28 days from the start of treatment
队列1：患者自CAR-T细胞输注后第2天开始，或在第2天前记录到2次体温≥38.5°C的发热后开始（以较早者为准），每12小时皮下注射阿那白滞素100 mg，持续10天。队列2：患者在T细胞输注第0天接受阿那白滞素100 mg皮下注射，此后每日一次，持续7天。
本研究旨在评估研究药物阿那白滞素能否预防或逆转CAR-T细胞治疗引起的严重副作用。
This study is being done to see if the investigational drug, anakinra, prevent or reverse the severe side effects caused by CAR-T cell therapy.
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