肿瘤细胞治疗研究
英文原题：CD30 CAR T-cells Post AutoHSCT for Poor-risk Hodgkin Lymphoma
这是一项 I/II 期注册临床试验，评估 CAR-T 细胞治疗霍奇金淋巴瘤的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 21 例。试验地点：美国 · 瓦尔哈拉（共 1 个中心）。登记号：NCT06617286。
不限性别 · ≥ 6 Years 且 ≤ 29 Years
纳入标准： • 签署知情同意时年龄≥6岁且≤29.99岁。 • Lansky或Karnofsky评分≥60%（见附录VI）。 • 确诊CD30阳性经典型霍奇金淋巴瘤，且符合ASCT条件；并符合以下任一疾病状态：诱导治疗失败、疾病进展或疾病复发（第1、2或3次）。 • 入组前通过再次活检确认复发、难治或持续存在的CD30阳性cHL。 • 至少符合以下既定危险因素中的2项：Karnofsky/Lansky体能评分<90%；诊断至首次复发时间<1年；复发/进展时存在结外受累；基线代谢性肿瘤体积（MTV）较高（18F-FDG PET/CT测得>60 mL）；首次再诱导治疗后仍为化疗耐药疾病（Deauville评分4–5）。 排除标准： • 不符合纳入标准。
Inclusion Criteria: * Age between ≥ 6 and ≤ 29.99 years at the time of consent. * Lansky OR Karnofsky score of ≥ 60% (see Appendix VI) * Disease Status: Confirmed diagnosis of CD30+ classical Hodgkin Lymphoma and meets eligibility to undergo ASCT. Must meet one of the following: Induction failure Progressive disease Disease relapse (1st, 2nd or 3rd) * Confirmatory re-biopsy of relapse/refractory/persistent CD30+ cHL prior to study entry. * Risk Factors: Patient must meet 2 or more of the established risk factors: Performance score (Karnofsky/Lansky) \<;90% Time from diagnosis to first relapse of \<1 year Extra nodal involvement at the time of relapse/progression High baseline metabolic tumor volume (MTV, \>60mL) by 18F-fluorodeoxyglucose positron emission tomography (PET)/computed tomography (CT) Chemo resistant disease (Deauville 4-5) after the first re-induction Exclusion Criteria: * not meeting the inclusion criteria
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 administering CAR T-cells · To evaluate the incidence of adverse events related to autologous CD30+ CAR T-cell infusions including not limited to infusions related reactions (IRR) (CTCAE 5.0), cytokine release syndrome (CRS) (ASCTC), and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) (ASCTC) and all general grade 3-5 toxicities (CTCAE 5.0) in children, adolescent, and young adult patients with poor-risk CD30+ cHL following MAC AutoHSCT. · 2 years；Feasibility of Central Manufacturing of CAR T-cells · To evaluate the feasibility of local site PBMC collection and central GMP CD30 CAR T cell manufacturing with a 75% success rate in children, adolescent, and young adult patients with poor-risk CD30+ cHL following MAC AutoHSCT. · 1 year
患者在自体造血干细胞移植后第21至42天接受自体CD30 CAR-T细胞。
预后不良的经典型霍奇金淋巴瘤（cHL）患者将接受自体造血干细胞移植（AutoHSCT）联合清髓性化疗（MAC），随后接受自体CD30阳性CAR-T细胞。
Patients with poor risk classical Hodgkin Lymphoma (cHL) will undergo myeloablative chemotherapy (MAC) with autologous stem cell transplantation (AutoHSCT) and subsequently receive autologous CD30+ CAR T-cells.
MEMBER ACCOUNT
登录成功会直接打开下一页。
