肿瘤细胞治疗研究
英文原题：CAR T-cell Therapy in Patients With Renal Dysfunction
这是一项 II 期注册临床试验，评估细胞治疗用于非霍奇金淋巴瘤、多发性骨髓瘤、急性淋巴细胞白血病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 20 例。试验地点：美国 · 亚特兰大（共 1 个中心）。登记号：NCT05909059。
不限性别 · ≥ 18 Years
纳入标准： • 在接受商业化CAR-T治疗多发性骨髓瘤、白血病或淋巴瘤前，接受淋巴细胞清除化疗。 • 骨髓功能足以接受淋巴细胞清除化疗。 • 肾功能≤60 mL/min/1.73 m²。 • ECOG体能状态评分0–2。 排除标准： • 相关中枢神经系统疾病。 • 活动性未控制感染，或研究者认为会干扰研究实施的其他合并疾病或状况。 • CAR-T给药前72小时内使用治疗剂量的全身性糖皮质激素（定义为泼尼松>20 mg/日或等效剂量）。
Inclusion Criteria: * Receiving lymphodepleting chemotherapy prior to commercial CAR-T administration for multiple myeloma, leukemia, or lymphoma * Adequate bone marrow function to receive lymphodepleting chemotherapy * Renal function \</= 60mL/min/1.73m2 * ECOG 0-2 Exclusion Criteria: * Relative CNS disorders * Active uncontrolled infection or any other concurrent disease or medical condition that was deemed to interfere with the conduct of the study as judged by the investigator * Use of therapeutic dose systemic corticosteroids (defined as \>20mg/day prednisone or equivalent) within 72 hours of CAR-T administration
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：Occurrence of CRS · Collection of maximum grade of CRS (based on CTCAE v5) and when this event occurs post CAR T cell therapy infusion · 90 days；Occurrence of ICANS · Collection of maximum grade of ICANs (based on CTCAE v5) and when this event occurs after CAR T cell therapy infusion · 90 days；Occurrence of Cytopenias · Collection of grade 3 or higher (based on CTCAE v5) cytopenias not resolved by Day 30 post CAR T cell infusion · 90 days
氟达拉滨剂量减少20%，环磷酰胺不减量。
氟达拉滨剂量减少40%，环磷酰胺不减量。
氟达拉滨剂量减少50%，环磷酰胺剂量减少25%。
这是一项前瞻性描述性研究，旨在评估中重度肾功能损害患者在接受剂量调整后的淋巴细胞清除化疗时实施CAR-T治疗的可行性。
This is a prospective, descriptive study designed to assess the feasibility of administering CAR T therapy among patients with moderate to severe renal impairment using dose adjusted lymphodepleting chemotherapy.
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