肿瘤细胞治疗研究
英文原题：CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Mantle Cell Lymphoma
⚠ 该试验的登记信息已有 35 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 II 期注册临床试验，评估 CD19CAR-T 细胞治疗套细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 59 例。试验地点：中国 · 北京、福州、广州、郑州（共 12 个中心，其中中国 12 个）。登记号：NCT04718883。
不限性别 · ≥ 18 Years
纳入标准：年龄≥18岁；签署知情同意书；组织学确诊套细胞淋巴瘤；疾病复发/难治；有可及的PET阳性病灶及按Lugano分类可测量的CT阳性病灶；ECOG 0-1分；预期生存期>12周；器官功能充分；白细胞单采有充分血管通路；既往接受靶向CD19治疗者须确认淋巴瘤病灶仍表达CD19；有生育能力的女性同意末次JWCAR029给药后1年内采取高效避孕；伴侣有生育可能的男性同意末次给药后1年内采取有效屏障避孕。排除标准：仅有中枢神经系统（CNS）恶性肿瘤受累或原发性CNS淋巴瘤；其他原发恶性肿瘤未缓解至少2年；筛查时HBV、HCV、HIV或梅毒感染；签署知情同意书前3个月内发生深静脉血栓（DVT）/肺栓塞（PE），或相关事件需抗凝治疗；未控制的全身性真菌、细菌、病毒或其他感染；活动性或慢性移植物抗宿主病（GVHD）；严重心血管疾病史或有临床意义的CNS病变；妊娠或哺乳；白细胞单采前使用过化疗、皮质类固醇、试验药物、GVHD治疗、放疗或其他淋巴瘤治疗且未完成规定洗脱期；既往接受异体造血干细胞移植；未控制的疾病，或不愿/不能遵守方案程序；既往接受CAR-T或其他基因修饰T细胞治疗。
Inclusion Criteria: * ≥ 18 years old; * Sign on the informed consent; * Subject must have histologically confirmed mantle cell lymphoma; * Relapsed/refractory patients; * Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification; * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; * Expected survival is greater than 12 weeks; * Adequate organ function; * Adequate vascular access for leukapheresis procedure; * Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19; * Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029; * Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029. Exclusion Criteria: * Central nervous system (CNS) only involvement by malignancy or primary CNS lymphoma; * History of another primary malignancy that has not been in remission for at least 2 years; * Subjects has HBV, HCV, HIV or syphilis infection at the time of screening; * Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF; * Subjects with uncontrolled systemic fungal, bacterial, viral or other infection; * Presence of acute or chronic graft-versus-host disease (GVHD); * History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; * Pregnant or nursing women; * Subjects using of any chemotherapy, corticosteriod, experiment agents, GVHD therapies, radiation or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; * Received allo-hematopoietic stem cell transplantation therapy previously. * Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; * Received CAR T-cell or other genetically-modified T-cell therapy previously.
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：Objective response rate (ORR) · Objective response rate (ORR) in 3 month in relapsed and refractory (R/R) mantle cell lymphoma (MCL) subjects · 3 months
次要终点：Complete response rate (CRR)；The best objective response rate；The best complete response rate；Number of participants with adverse events (AEs)；Type of adverse events (AEs)；Severity of adverse events(AEs)；Number of participants with laboratory abnormalities；Type of laboratory abnormalities
JWCAR029给药剂量为1×10^8个CAR阳性T细胞。
这是一项II期、开放标签、单臂、多中心研究，评估JWCAR029治疗中国成年复发/难治性套细胞淋巴瘤患者的疗效和安全性。
This is a phase II, open-label, single-arm, multicenter study to assess the efficacy and safety of JWCAR029 in adult R/R Mantle Cell Lymphoma subjects in China.
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