肿瘤细胞治疗研究
英文原题：A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。
这是一项 I/II 期注册临床试验，评估细胞治疗用于急性淋巴细胞白血病的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 153 例。试验地点：美国 · 杜阿尔特、拉霍亚、萨克拉门托、旧金山（共 34 个中心）。登记号：NCT04404660。
不限性别 · ≥ 18 Years
纳入标准： • 年龄≥18岁。 • ECOG体能状态评分0或1。 • 复发/难治性B细胞ALL。 • Ph阳性ALL患者若对TKI不耐受、既往两线任何TKI治疗失败、第二代TKI一线治疗失败，或存在TKI禁忌证，可入组。 • 筛查前1个月内有文件记录CD19阳性。 • Ib期主要队列IA：筛查时骨髓原始细胞≥5%。 • Ib期探索性队列IB：筛查时MRD阳性，定义为骨髓原始细胞≥1×10⁻⁴且<5%。 • II期主要队列IIA：筛查时骨髓原始细胞≥5%。 • II期队列IIB：达到≥第二次完全缓解（CR）或血细胞计数不完全恢复的完全缓解（CRi），中央NGS检测MRD阳性（≥1×10⁻³），且筛查时骨髓原始细胞<5%。 • 肾、肝、肺及心功能充分。 排除标准： • Ib期（队列IA/IB）或II期（队列IIA/IIB）B-ALL患者仅有髓外疾病。 • 确诊Burkitt白血病/淋巴瘤，或慢性髓性白血病（CML）淋巴母细胞急变。 • 有临床相关中枢神经系统（CNS）病变史或当前病变。 • CNS-3疾病，或伴神经系统改变的CNS-2疾病。 • 存在活动性或未控制的真菌、细菌、病毒或其他感染，且需要全身抗菌药物治疗。 • 活动性或潜伏性乙型肝炎病毒感染，或活动性丙型肝炎病毒感染。 • HIV、HTLV-1、HTLV-2或梅毒检测阳性。 • 既往接受除blinatumomab以外的CD19靶向治疗；或blinatumomab治疗后发生过≥3级神经毒性。
Inclusion Criteria: * Age 18 years or older * ECOG performance status of 0 or 1 * Relapsed or refractory B cell ALL * Patients with Ph+ ALL are eligible if intolerant to TKI, failed two lines of any TKI, or failed one line of second-generation TKI, or if TKI is contraindicated * Documented CD19 positivity within 1 month of screening * Phase 1b: Primary Cohort IA: Presence of ≥5% blasts in BM at screening * Phase 1b: Exploratory Cohort IB: MRD-positive defined as ≥ 1e-4 and \<5% blasts in the BM at screening * Phase 2: Primary Cohort IIA: Presence of ≥5% blasts in BM at screening * Phase 2: Cohort IIB: ≥2nd CR or CRi with MRD-positive defined as ≥1e-3 by central NGS testing and \<5% blasts in the BM at screening * Adequate renal, hepatic, pulmonary, and cardiac function Exclusion Criteria: * Phase 1b (Cohort IA and Cohort IB) and Phase 2 (Cohort IIA and Cohort IIB) B-ALL with isolated EM disease * Diagnosis of Burkitt's leukaemia/lymphoma or CML lymphoid in blast crisis * History or presence of clinically relevant CNS pathology * Presence of CNS-3 disease or CNS-2 disease with neurological changes * Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management * Active or latent Hepatitis B virus or active Hepatitis C virus * Human Immunodeficiency Virus (HIV), HTLV-1, HTLV-2, syphilis positive test * Prior CD19 targeted therapy other than blinatumomab. Patients who have experienced Grade 3 or higher neurotoxicity following blinatumomab.
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 1b - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion · Up to 24 months；Phase 2 - Cohort IIA: ORR defined as proportion of patients achieving CR or CRi as assessed by an IRRC. · Up to 24 months
次要终点：Phase 2 - Proportion of patients achieving MRD-negative CR；Phase 2 - Complete remission rate；Phase 2 - Response to AUTO1 treatment measured as duration of remission (DOR)；Phase 2 - Response to AUTO1 measured as progression-free survival (PFS).；Phase 2 -Response to AUTO1 treatment measured as overall survival (OS)；Phase 2 - Frequency and severity of AEs and SAEs；Phase 2 - Incidence of severe hypogammaglobulinemia；Phase 2 - Duration of severe hypogammaglobulinemia
这是一项Ib/II期研究，评估靶向CD19的嵌合抗原受体（CAR）工程化自体T细胞治疗成人复发/难治性（r/r）B细胞急性淋巴细胞白血病（ALL）患者的安全性和疗效。
This is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (ALL).
MEMBER ACCOUNT
登录成功会直接打开下一页。
