肿瘤细胞治疗研究
英文原题：A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma
这是一项 I/II 期注册临床试验，评估细胞治疗用于大 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 112 例。试验地点：中国 · 北京、重庆、广州、杭州（共 15 个中心，其中中国 15 个）。登记号：NCT05800977。
不限性别 · ≥ 18 Years
纳入标准： * 年龄≥18岁； * 组织学证实为CD19或CD20阳性的B细胞非霍奇金淋巴瘤，疾病类型符合2016年WHO淋巴肿瘤分类，包括： 1. 非特指型弥漫性大B细胞淋巴瘤（DLBCL，NOS）； 2. 原发性纵隔大B细胞淋巴瘤（PMBCL）； 3. 转化型滤泡性淋巴瘤（tFL）； 4. MYC和BCL2和/或BCL6重排的高级别B细胞淋巴瘤（HGBL-DH/TH）； 5. 非特指型高级别B细胞淋巴瘤（HGBL，NOS）； 6. 3B级滤泡性淋巴瘤（FL3B）； * 至少接受过两线标准治疗后复发/难治，或自体干细胞移植（ASCT）后复发； * 按2014年Lugano分类至少有一个可测量病灶； * 器官及骨髓功能充分。 排除标准： * 既往任何时间接受过异体造血干细胞移植（HSCT），或采集单采细胞前12周内接受过ASCT； * 疑似或确诊中枢神经系统受累； * 签署知情同意书前6个月内发生过卒中或惊厥； * 自身免疫性疾病、免疫缺陷，或需接受免疫抑制剂治疗的疾病； * 未控制的活动性感染； * 乙肝表面抗原（HBsAg）或乙肝核心抗体（HBcAb）阳性且外周血可检出乙肝病毒（HBV）DNA；丙肝抗体阳性且外周血HCV RNA阳性；HIV抗体阳性；梅毒检测阳性； * 严重心脏、肝脏、肾脏或代谢性疾病； * 采集单采细胞前既往抗肿瘤治疗的洗脱期不足； * 既往接受过CAR-T治疗。
Inclusion Criteria: * ≥ 18 years of age * Histologically confirmed CD19 or CD20 positive B-cell non-Hodgkin lymphoma, including the following neoplasms as defined by the 2016 WHO classification of lymphoid neoplasms: 1. Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) 2. Primary mediastinal large B-cell lymphoma (PMBCL) 3. Transformed follicular lymphoma (tFL) 4. High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (HGBL-DH/TH) 5. High-grade B-cell lymphoma, NOS (HGBL, NOS) 6. Follicular lymphoma grade 3B (FL3B) * Relapsed or refractory disease after ≥ 2 lines of standard therapy or relapsed after autologous stem cell transplantation (ASCT) * At least one measurable lesion per the Lugano 2014 Classification * Adequate organ and marrow function Exclusion Criteria: * Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or ASCT within 12 weeks prior to apheresis * Suspected or confirmed central nervous system involvement * Stroke or convulsion history within 6 months of signing informed consent form (ICF) * Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment * Uncontrolled active infection * Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human immunodeficiency virus (HIV) antibody; positive syphilis test * Severe heart, liver, renal or metabolism disease * Inadequate wash-out time for previous anti-tumor treatments prior to apheresis * Prior CAR-T 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：Phase 1b: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) · Incidence and severity of TEAEs , including dose limiting toxicities (DLTs) · Up to 90 days after C-CAR039 infusion；Phase 1b: Recommended Phase 2 Dose (R2PD) · Based on DLTs rates and overall safety profile · Up to 3 months after C-CAR039 infusion；Phase 2: Overall Response Rate (ORR) at 3 months · Best response rate at 3 months after C-CAR039 infusion, including partial response (PR) and complete response (CR) · Up to 3 months after C-CAR039 infusion
次要终点：Phase 1b: Incidence and Severity of Adverse Events (AEs)；Phase 1b: ORR at 3 months；Phase 2: Incidence and Severity of Adverse Events (AEs)；ORR；ORR at 6 months；Duration of response (DOR)；Time to response (TTR)；Progression-free survival (PFS)
完成淋巴细胞清除治疗后，静脉单次输注Prizlon-cel。
这是一项多中心、单臂、开放标签研究，旨在评估普利佐卡布他基因自体细胞（Prizlon-cel）的安全性并确定Ⅱ期推荐剂量（Ⅰb期），以及评估其治疗复发或难治性大B细胞淋巴瘤患者的疗效（Ⅱ期）。
This is a multicenter, single arm, open-label study. The purpose of the study is to evaluate safety of Prizloncabtagene Autoleucel (Prizlon-cel) and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of Prizlon-cel (Phase 2) in patients with relapsed or refractory large b-cell lymphoma (LBCL).
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