肿瘤细胞治疗研究
英文原题：CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) Large B-cell Lymphoma
CD19-targeted CAR T Cells for Relapsed or Refractory (R/R) 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 II 期注册临床试验，评估细胞治疗用于非霍奇金淋巴瘤、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 12 例。试验地点：中国 · 天津（共 1 个中心，其中中国 1 个）。登记号：NCT06479356。
不限性别 · ≥ 18 Years
纳入标准：年龄≥18岁；签署知情同意书；组织学确诊大B细胞淋巴瘤；既往接受过蒽环类药物及利妥昔单抗（或其他抗CD20抗体）治疗，在至少两线治疗（包括自体造血干细胞移植，auto-HSCT）后复发、无应答或疾病进展；存在可及的PET阳性病灶及按Lugano分类可测量的CT阳性病灶；ECOG 0-1分；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瑞基奥仑赛给药后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：原发性中枢神经系统淋巴瘤；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；活动性深静脉血栓（DVT）/肺栓塞（PE），或签署知情同意书前3个月内发生需抗凝治疗的活动性DVT/PE；未控制的全身性真菌、细菌、病毒或其他感染；急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；白细胞单采前使用化疗、皮质类固醇、试验药物、GVHD治疗、放疗、异体HSCT或其他淋巴瘤治疗但未完成规定洗脱期；未控制的疾病，或不愿/不能遵守方案程序；既往接受CAR-T细胞或其他基因修饰T细胞治疗。
Inclusion Criteria: 1. ≥18 years old; 2. Sign on the informed consent; 3. Subjects must have histologically confirmed Large B-cell Lymphoma; 4. Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-HSCT); 5. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification; 6. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1; 7. Adequate organ function; 8. Adequate vascular access for leukapheresis procedure; 9. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19; 10. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel; 11. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel. Exclusion Criteria: 1. Primary CNS lymphoma; 2. History of another primary malignancy that has not been in remission for at least 2 years; 3. Subjects has HBV,HCV,HIV or syphilis infection at the time of screening; 4. Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-coagulation within 3 months prior to signing the ICF; 5. Subjects with uncontrolled systemic fungal,bacterial,viral or other infection; 6. Presence of acute or chronic graft-versus-host disease(GVHD); 7. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology; 8. Pregnant or nursing woman; 9. Subjects using of any chemotherapy,corticosteroid,experiment agents,GVHD therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis; 10. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol; 11. 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) in LBCL subjects · Objective response rate (ORR) in 3 month evaluated by investigator of LBCL subjects · 3 months
次要终点：Objective response rate (ORR)；Best objective response rate ( Best ORR) in LBCL subjects；Complete response rate (CRR) in LBCL subjects；Progression-free survival (PFS)；Overall survival (OS)；Duration of response (DOR)；Pharmacokinetic(PK)-Cmax of Relma-cel；Pharmacokinetic(PK)-Tmax of Relma-cel
评估1×10^8个CAR阳性T细胞剂量水平下瑞基奥仑赛的疗效、安全性及药代动力学。
本研究为开放标签、单臂研究，使用瑞基奥仑赛（relma-cel）治疗中国成年复发/难治性大B细胞淋巴瘤患者。
This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.
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