肿瘤细胞治疗研究
英文原题：AB-2100, an Integrated Circuit T Cell Therapy in Patients With Recurrent Clear-cell Renal Cell Carcinoma (ccRCC)
⚠ 该试验的登记信息已有 12 个月未更新， 页面上显示的「进行中（不再招募）」可能已经失效。联系研究中心之前，建议先到 ClinicalTrials.gov 核对登记原文的最新状态与联系方式。
这是一项 I/II 期注册临床试验，评估细胞治疗用于肾细胞癌的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 37 例。试验地点：美国 · 凤凰城、杜阿尔特、坦帕、艾奥瓦城（共 9 个中心）。登记号：NCT06245915。
不限性别 · ≥ 18 Years
纳入标准： • 晚期或转移性透明细胞肾细胞癌（ccRCC）。 • 在晚期或转移性阶段接受过免疫检查点抑制剂和 VEGF 靶向治疗；末次方案治疗期间或之后有疾病进展证据，或因不可接受的毒性停药。 • 按方案定义的重要器官功能充分。 • ECOG 体能状态评分0或1。 • 入组时按方案定义存在可测量疾病。 • 有生育能力的女性和男性同意从入组至 AB-2100 输注后至少12个月使用认可的避孕措施。 排除标准： • 细胞采集前14天内接受过任何系统性肾癌治疗（若末次治疗含抗体类药物，间隔须为28天）。 • 预处理化疗开始前14天内接受过系统性抗癌治疗（若末次治疗含抗体类药物，间隔须为28天）。 • 预处理化疗开始前8周内接受过研究性细胞治疗。 • 既往接受过抗 CA9 治疗。 • 筛查前6个月内发生心肌梗死或不稳定型心绞痛。 • 筛查前28天内存在需引流以缓解症状的胸腔积液。 • 活动性自身免疫病需免疫抑制治疗，或经治疗仍未控制。 • 未治疗的脑转移。 • 不愿参加延长安全性监测期。
Inclusion Criteria: * Advanced or metastatic clear-cell renal cell carcinoma * Must have received an immune checkpoint inhibitor and a VEGF-targeted therapy in the advanced or metastatic setting. Must have evidence of progression on or after the last treatment regimen or discontinued treatment for unacceptable toxicity. * Adequate organ function as per protocol definitions. * Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1. * Measurable disease at time of enrollment as per protocol definitions. * Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after AB-2100 infusion. Exclusion Criteria: * Any prior systemic RCC therapy within 14 days of time of cell collection (interval of 28 days will be required if the last immediate treatment contained an antibody-based agent). * Systemic anti-cancer therapy within 14 days of starting of conditioning chemotherapy (interval of 28 days will be required if the last immediate treatment contained an antibody-based agent) * Investigational cellular therapies within 8 weeks prior to start of conditioning chemotherapy * Prior treatment with anti-CA9 therapies * Myocardial infarction or unstable angina within 6 months prior to screening * Pleural effusion that requires drainage for symptom management within 28 days of screening. * Active autoimmune disease requiring immunosuppressive therapy or uncontrolled with treatment. * Untreated brain metastasis. * Subjects unwilling to participate in an extended safety monitoring period.
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：Phase 1 (Dose escalation): incidence of adverse events · Defined as dose-limiting toxicities based on a 3+3 dose escalation study design · From AB-2100 infusion up to 21 days post infusion；Phase 2 (Cohort expansion): Objective response rate (ORR) · ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to RECIST v1.1 · From AB-2100 infusion up to 24 months post-infusion
患者于第0天单次静脉输注 AB-2100。部分患者可在输注前接受预处理化疗。
这项多中心、开放标签 I/II 期试验评估 AB-2100 细胞产品的安全性和疗效。I 期预计纳入约60名患者，II 期预计纳入约70名患者。
This is a multi-center, open-label phase 1/2 trial evaluating the safety and efficacy of AB-2100 cell product. The study may enroll approximately 60 patients in phase 1 and approximately 70 patients in phase 2.
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