肿瘤细胞治疗研究
英文原题：A Multicenter, Open-label, Non-randomized, Single-arm Phase 1/2 Study of Autologous Nano CD5-CAR T Cells for the Treatment of Relapsed/Refractory T-cell Acute Lymphoblastic Leukemia/Lymphoma
这是一项 I/II 期注册临床试验，评估自体 CAR-T 细胞治疗急性淋巴细胞白血病、淋巴瘤、血液系统恶性肿瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 18 例。登记号：NCT07678307。
不限性别 · ≥ 3 Years 且 ≤ 70 Years
纳入标准： • 年龄3至70岁。 • 确诊CD5阳性复发/难治性T细胞急性淋巴细胞白血病（T-ALL）或T细胞淋巴母细胞淋巴瘤（T-LBL）。 • ECOG体能状态评分0–2。 • 肾、肝、心脏及肺功能充分。 • 能够理解并签署知情同意。 排除标准： • 活动性严重感染或未控制的脓毒症。 • 过去3个月内接受过异基因造血干细胞移植。 • 严重自身免疫性疾病或免疫缺陷。 • 既往接受过靶向CD5的治疗。 • 妊娠或哺乳期女性。 • 研究者认为会危及安全或影响遵守研究方案的任何情况。
Inclusion Criteria: * Age 3 to 70 years old * Diagnosed with CD5-positive relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) * ECOG performance status 0-2 * Adequate organ function (renal, hepatic, cardiac, pulmonary) * Able to understand and sign informed consent Exclusion Criteria: * Active severe infection or uncontrolled sepsis * History of allogeneic stem cell transplantation within 3 months * Severe autoimmune disease or immunodeficiency * Prior CD5-targeted therapy * Pregnant or breastfeeding women * Any condition that, in the investigator's opinion, would compromise safety or compliance with the protocol
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：Incidence of Dose-Limiting Toxicities (DLT) · Proportion of patients experiencing dose-limiting toxicities (DLT) within 28 days after CAR-T infusion, to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). · 28 days after CAR-T cell infusion
所有入组患者接受氟达拉滨（30 mg/m²/日，连续3天）和环磷酰胺（250 mg/m²/日，连续3天）淋巴细胞清除化疗，随后单次静脉输注自体纳米CD5-CAR T细胞。研究采用剂量递增设计，主要剂量水平为1.0×10⁶和2.0×10⁶个细胞/kg，并设有0.5×10⁶个细胞/kg的备用低剂量。
这是一项面向复发/难治性T细胞急性淋巴细胞白血病或T细胞淋巴瘤患者的临床研究。 研究将测试一种名为“自体纳米CD5-CAR T细胞”的新疗法。这些细胞取自患者自身的免疫细胞，并在实验室中改造，使其能够识别和杀死癌细胞。 研究分两部分：I期用于评估治疗安全性并确定最佳剂量，II期评估疗效。符合所有入选标准者可接受研究治疗。研究主要评估安全性、肿瘤缓解/改善人数及疗效持续时间。 可能风险包括发热、低血压和感染，研究团队将密切监测。
This is a clinical research study for people with relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoma. The study will test a new treatment called "autologous nano CD5-CAR T cells". These are your own immune cells that have been changed in a lab to recognize and kill cancer cells. This study has two parts: Phase 1 to test the safety and best dose of the treatment, and Phase 2 to see how well it works. You may receive the study treatment if you meet all the eligibility criteria. The main things the study will look at are: how safe the treatment is, how many people's cancer goes away or gets better, and how long the effect lasts. Possible risks include fever, low blood pressure, and infection, which the study team will monitor closely.
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