肿瘤细胞治疗研究
英文原题：Bio-CAR-T BS Study
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、大 B 细胞淋巴瘤、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 45 例。试验地点：欧洲 · 布雷西亚（共 1 个中心）。登记号：NCT05366569。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准： • B 细胞 ALL 患者年龄≤25岁；或 DLBCL/PMBCL 患者年龄18–70岁，且经过两线治疗后复发/难治。 • 体能状态良好（评分0或1）。 • 器官功能充分。 • 无活动性或未控制感染。 • 过去6个月内无血栓栓塞事件。 • 无具有临床意义的合并症（如过去24个月内导致器官功能障碍或需免疫抑制治疗的特定心血管、神经或免疫疾病）。 • 预期生存期至少3个月。 排除标准： • B 细胞 ALL 患者年龄>25岁。 • DLBCL 患者年龄<18岁或>70岁。 • PMBCL 患者年龄<18岁或>70岁。 • 体能状态评分>1。 • 活动性或未控制感染。 • 过去6个月内发生血栓栓塞事件。 • 存在具有临床意义的合并症（如过去24个月内导致器官功能障碍或需免疫抑制治疗的特定心血管、神经或免疫疾病）。 • 预期生存期<3个月。
Inclusion Criteria: * Patients with B-cell-ALL (≤ 25 years) or patients with DLBCL (18-70 years) or patients with PMBCL (18-70 years) who were relapsed/refractory after two lines of treatments; * Adequate performance status (0 or 1); * Adequate organ function; * No active or uncontrolled infections; * No thrombo-embolisms within the last 6 months; * Absence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months); * Life expectancy of at least 3 months. Exclusion Criteria: * Patients with B-cell-ALL \> 25 years * Patients with DLBCL \<18 or \>70 years * Patients with PMBCL \<18 or \>70 years * Performance status \> 1; * Active or uncontrolled infections; * Thrombo-embolisms within the last 6 months; * Presence of clinically relevant co-morbidities (e.g., select cardiovascular, neurologic, or immune disorders with organ dysfunction or requiring immunosuppressive treatment in the last 24 months); * Life expectancy \< 3 months.
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：Evaluation of change post-infusion CAR-T cell expansion and persistence in patients with DLBCL, PMBCL and ALL undergoing CAR-T therapy evaluated by flow-cytometry and measures by number of cells/mL · At day +1; +3; +7; +10; +14; +21; +30; +60; +90; +120; +150; +180; +210; +240; +270; +300; +330; +360 post CAR-T cell infusion or at any time for relapse/CRS-ICANS onset (assessed up to 2 years))；Change of disease burden after CAR-T Cells treatment · Disease response will be evaluated according to Lugano criteria · At day +30; +90; +180; 270 and + 360 post CAR-T infusion
次要终点：Number of participants with treatment-related adverse events as assessed by CTCAE v 4.0 and ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells；Evaluation of disease persistence and immune recovery and neurological biomarkers after CAR-T infusion；Evaluation of plasma level of biomarkers for ICANS neural damage and glial activation in patients who develop ICANS.
本研究评估接受 CAR-T 治疗的弥漫性大 B 细胞淋巴瘤（DLBCL）、原发性纵隔大 B 细胞淋巴瘤（PMBCL）和急性淋巴细胞白血病（ALL）患者输注后 CAR-T 细胞的扩增和持续性，并评价真实临床实践中的治疗可行性和疗效。
The aim of this Study is the evaluation of post-infusion CAR-T (Chimeric Antigen Receptor T Cell) expansion and persistence in patients with DLBCL, PMBCL and ALL undergoing CAR-T therapy; and the feasibility and efficacy of the treatment in the real life practice.
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