肿瘤细胞治疗研究
英文原题：Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors
Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors
这是一项早期 I 期注册临床试验，评估 CAR-T 细胞治疗实体瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 24 例。试验地点：中国 · 南京（共 1 个中心，其中中国 1 个）。登记号：NCT07487597。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准： 1. 受试者自愿提供书面知情同意。 2. 年龄18至70岁（含界值）。 3. 预期生存期≥3个月。 4. ECOG体能状态评分0至1。 5. 标准治疗失败或不适合标准治疗。 6. 至少有一个符合RECIST 1.1标准的可测量病灶。 7. 免疫组化证实肿瘤为ALPP阳性。 8. 器官和骨髓功能足够。 9. 有生育能力的受试者须采取有效避孕措施。 10. 静脉通路适合白细胞单采。 排除标准： 1. 原发性中枢神经系统恶性肿瘤或未控制的中枢神经系统转移。 2. 5年内患有其他恶性肿瘤（充分治疗的非黑色素瘤皮肤癌或原位癌除外）。 3. 活动性自身免疫性疾病或自身免疫性疾病史。 4. 免疫缺陷，包括HIV阳性。 5. 出血性疾病（遗传性或获得性）。 6. 有临床意义的心血管疾病。 7. 活动性感染（包括结核、乙型/丙型肝炎、梅毒）。 8. 妊娠或哺乳期女性。 9. 有难治性癫痫、活动性消化道出血或肿瘤出血高风险史。 10. 严重全身性或精神疾病。 11. 既往接受过细胞或基因治疗。 12. 有严重药物过敏史。 13. 研究者评估认为不适合参加试验。
Inclusion Criteria: 1. Participants must voluntarily provide written informed consent. 2. Aged 18-70 years (inclusive). 3. Life expectancy ≥ 3 months. 4. ECOG performance status 0-1. 5. Failed or unsuitable for standard therapy. 6. At least one measurable lesion per RECIST 1.1. 7. ALPP-positive tumor confirmed by immunohistochemistry. 8. Adequate organ and bone marrow function. 9. Effective contraception required for participants of childbearing potential. 10. Adequate venous access for leukapheresis. Exclusion Criteria: 1. Primary CNS malignancy or uncontrolled CNS metastases. 2. Other malignancies within 5 years (except adequately treated non-melanoma skin cancer or carcinoma in situ). 3. Active autoimmune disease or history of autoimmune disease. 4. Immunodeficiency, including HIV positivity. 5. Bleeding disorders (inherited or acquired). 6. Clinically significant cardiovascular disease. 7. Active infection (including tuberculosis, hepatitis B/C, syphilis). 8. Pregnant or breastfeeding women. 9. History of refractory epilepsy, active GI bleeding, or high risk of tumor bleeding. 10. Severe systemic or psychiatric illness. 11. Prior cell or gene therapy. 12. Severe drug hypersensitivity history. 13. Investigator-assessed unsuitability for trial participation.
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：Safety of Enhanced ALPP CAR-T cells · The incidence, type, and severity of all adverse events, serious adverse events, and abnormal laboratory findings. · Up to 24 months；Safety of Enhanced ALPP CAR-T cells · Incidence of DLT · Up to 1 month
次要终点：Efficacy of Enhanced ALPP CAR-T cells；To investigate the Cmax of Enhanced ALPP CAR-T cells in the peripheral blood after infusion；To assess Enhanced ALPP CAR-T cell trafficking into tumor tissues after infusion；To investigate the AUC of Enhanced ALPP CAR-T cells in the peripheral blood after infusion
参与者接受淋巴细胞清除化疗后，输注增强型ALPP CAR-T细胞。
这是一项单臂、开放标签、剂量递增临床试验，评估功能增强型ALPP靶向工程化T细胞（简称增强型ALPP CAR-T）用于既往治疗后进展的ALPP阳性复发或转移性实体瘤患者的安全性、耐受性、扩增和持续性。主要目标是确定最大耐受剂量（MTD），次要目标是评估其治疗实体瘤的初步临床疗效。
This is a single-arm, open-label, dose-escalation clinical trial designed to evaluate the safety, tolerability, expansion, and persistence of functionally enhanced ALPP-targeted engineered T Cells (Herein referred to as Enhanced ALPP CAR-T) in patients with ALPP-positive recurrent or metastatic solid tumors who have progressed after prior therapies. The primary objective is to determine the maximum tolerated dose (MTD), with a secondary aim to assess preliminary clinical efficacy in solid tumors.
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