肿瘤细胞治疗研究
英文原题：Dynamic Individualized Risk Profiling of Patients With Relapsed/Refractory Lymphoid Malignancies and CD19-CAR T Cell Therapy (INTeRCePT 2.0)
这是一项分期未标注的注册临床试验，评估细胞治疗用于淋巴瘤、血液系统恶性肿瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 50 例。试验地点：欧洲 · 苏黎世（共 1 个中心）。登记号：NCT07472972。
不限性别
纳入标准： • 登记前且任何试验特定程序开始前签署书面知情同意。 • 年龄≥18岁。 • 按 WHO 2022 分类确诊复发/难治性 B 细胞淋巴瘤。 • 按疾病特异性反应标准（如 Lugano 2014 标准）有可测量疾病。 • 按临床标准治疗计划接受 CD19 靶向 CAR-T 细胞治疗。 • 愿意在指定临床访视时提供外周血和活检样本。 排除标准： • 治疗医生判断存在妨碍开始 CD19 靶向 CAR-T 治疗的情况，如哺乳、妊娠或感染等。 • 治疗医生判断存在妨碍完成所需研究程序的合并医疗或心理状况。 • 不愿意或无法遵守研究方案。
Inclusion Criteria: * Written informed consent before registration and prior to any trial specific procedures * Participants ≥ 18 years of age * Diagnosis of relapse/refractory B-cell lymphoma according to WHO 2022 classification * Measurable disease per response criteria specific to the disease e.g. per Lugano 2014 criteria * Patients planned for CD19-redirected CAR T cell therapy according to clinical standard of care * Patients who are willing to donate peripheral blood and biopsy material at indicated clinical visits Exclusion Criteria: * Any condition, which precludes initiation of CD19-redirected CAR T cell therapy (e.g. breast feeding, pregnancy, infections, etc.) as judged by the treating physician * Any coexisting medical or psychological condition that would preclude participation in the required study procedures, as judged by the treating physician * Unwillingness or inability to comply 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：Feasibilty of INTeRCePT assay · Risk profiling is performed by the INTeRCePT assay, which is a combinatorial, in-depth analysis of disease load (Liquid Biopsy, PET-CT/-MRI), immune environment "fitness" (scCytometry), performance status (ECOG) and inflammation status (InflaMix). The primary endpoint is the rate of successful completion of the INTeRCePT assay by day 38 post CAR T infusion (% of patients with complete INTeRCePT assay). · From enrollment until day28 post CAR T Infusion
次要终点：Rate of accurate prediction of complete response (CR vs. no CR) at month 3 post-CAR T infusion by the INTeRCePT assay
纳入接受 CD19 CAR-T 治疗的复发/难治性淋巴系统恶性肿瘤患者。
INTeRCePT 2 研究旨在开发预测检测，识别最可能对 CAR-T 治疗产生应答的 B 细胞淋巴瘤患者。该检测纵向整合五个组成部分：循环肿瘤 DNA（CAPPseq）、外周血炎症指标（InflaMIX）、PET-CT 影像参数、流式细胞术评估的免疫细胞谱和 ECOG 体能状态。本试验将评估该综合检测的可行性，以期改进治疗选择并为接受 CAR-T 的淋巴瘤患者提供更个体化的治疗决策。
The INTeRCePT 2 study aims to develop a predictive assay to determine which patients with B cell lymphoma are most likely to respond to CAR T cell therapy. This assay combines five components for longitudinal profiling of each patient. The goal of the trial is that the assay can be completed (feasibility). This comprehensive assay integrates five key components including circulating tumor DNA (CAPPseq), inflammation markers from peripheral blood tests (InflaMIX), PET CT imaging parameters, immune cell profiles (flow cytometry), and performance status (ECOG). Ultimately, this tool could improve treatment selection, and guide more personalized therapy decisions for lymphoma patients receiving CAR T cells.
MEMBER ACCOUNT
登录成功会直接打开下一页。
