肿瘤细胞治疗研究
英文原题：An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
An Open-label, Single-arm Study of JWCAR201 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
⚠ 该试验的登记信息已有 26 个月未更新， 页面上显示的「招募中」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 期注册临床试验，评估细胞治疗用于弥漫大 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 9 例。试验地点：中国 · 上海（共 1 个中心，其中中国 1 个）。登记号：NCT06517004。
不限性别 · ≥ 18 Years
纳入标准：年龄≥18岁；自愿参加研究并签署书面知情同意书；组织学确诊且免疫组化CD20阳性DLBCL；既往接受蒽环类药物和抗CD20方案治疗，且至少两线标准治疗或自体造血干细胞移植（HSCT）后疾病难治或复发；至少一个符合Lugano标准、由CT或PET评估的可测量病灶；ECOG≤1分；器官功能充分；白细胞单采静脉通路充分；有生育能力的女性同意输注后1年内采取有效可靠避孕方法；未行输精管结扎且与有生育能力女性有性生活的男性同意输注后1年内采取屏障避孕。排除标准：原发性中枢神经系统淋巴瘤；2年内其他原发恶性肿瘤；活动性HBV、HCV、HIV或梅毒感染；过去3个月内严重活动性深静脉血栓或肺栓塞；过去3个月内因严重活动性深静脉血栓或肺栓塞接受抗凝治疗（预防性使用除外）；未控制或活动性感染；急性或慢性GVHD；过去6个月内严重心血管疾病；过去6个月内有临床意义的严重CNS疾病；妊娠或哺乳；白细胞单采前未满足规定的洗脱期；研究者判定不能或不愿遵守方案，或其他不适合参加研究的情况；既往接受任何基因工程修饰T细胞治疗或其他细胞/基因治疗。
Inclusion Criteria: 1. Age ≥18 2. Voluntarily willing to participate in the study and sign the written informed consent form 3. Histologically confirmed diffuse large B-cell lymphoma (DLBCL) with immunohistochemistry (IHC) CD20-positive 4. Patients must be priorly treated by Anthracyclines and anti-CD20-targeted regimens, and must be refractory or relapsed to at least ≥2 treatment lines of standard of care or autologous hematopoietic stem-cell transplantation (HSCT) 5. At least one measurable lesion by CT or PET per Lugano criteria 6. Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1 7. Adequate organ functions 8. Adequate venous access for apheresis 9. Women of childbearing potential must agree to use an effective and reliable contraceptive method till 1-year post-infusion 10. Male patients who have not undergone vasectomy and have sexual activity with women of childbearing potential must agree to the use of a barrier contraceptive till 1-year post-infusion Exclusion Criteria: 1. Primary central nervous system lymphoma 2. Another primary malignancy within 2 years 3. Active infections of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis 4. With severe active deep venous thrombosis or pulmonary embolism within 3 months 5. Treated with anti-coagulations (except for prophylaxis use) due to severe active deep venous thrombosis or pulmonary embolism within 3 months 6. Uncontrolled or active infection 7. Acute or chronic graft-versus-host disease (GvHD) 8. With severe cardiovascular diseases within 6 months 9. With severe clinically-significant central nervous system disorders within 6 months 10. Pregnant or lactating women 11. Not satisfying pre-defined wash-out period for apheresis 12. Unable or unwilling to comply with the study protocol, judged by the investigator, or other situations implying that the subject might not be appropriate to participate in the study 13. Previously treated with any genetically engineered modified T-cell therapy nor other cell-gene therapy
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：Rate of dose-limiting toxicities (DLTs) · Dose limiting toxicities for each subject · 28 days；AE/SAE · Incidence and severity of adverse events (AE), and serious adverse event (SAE) · 24 months
次要终点：Copy number of the vector transgene of JWCAR201 in peripheral blood；CD19-positive cells and CD20-positive cells in peripheral blood；Objective response rate (ORR)；Complete response rate (CRR)；Duration of response (DOR)；Progression-free survival (PFS)；Overall survival (OS)
经氟达拉滨和环磷酰胺清除淋巴细胞后，给予患者自体CD19/CD20定向CAR-T细胞。
这是一项开放标签、单臂研究，旨在评估JWCAR201治疗复发或难治性弥漫大B细胞淋巴瘤（DLBCL）受试者的疗效和安全性信号。
This is an open-label, single-arm study to investigate the efficacy and safety signals of JWCAR201 amongst subjects with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
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