肿瘤细胞治疗研究
英文原题：A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
这是一项 III 期注册临床试验，评估细胞治疗用于大 B 细胞淋巴瘤、淋巴瘤、非霍奇金淋巴瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 400 例。试验地点：美国 · 吉尔伯特、斯科茨代尔、小石城、洛杉矶（共 36 个中心）。登记号：NCT07188558。
不限性别 · ≥ 18 Years
主要纳入标准： 1. 未接受过 CAR T 细胞治疗且有资格接受 CD19 CAR T 细胞治疗 2. 组织学确诊的大 B 细胞淋巴瘤，包括（WHO 2022）或国际共识分类（2022）定义的以下类型 * 弥漫性大 B 细胞淋巴瘤（DLBCL） * 惰性 B 细胞淋巴瘤的转化（除外 Richter 转化） * 伴有 MYC 和 BCL2 重排的 DLBCL/高级别 B 细胞淋巴瘤（HGBCL） * 非特指型高级别 B 细胞淋巴瘤（HGBCL NOS） * 原发纵隔大 B 细胞淋巴瘤（PMBCL） * 3B 级滤泡性淋巴瘤/大细胞滤泡性淋巴瘤（FL3B） 3. 在接受含抗 CD20 抗体和蒽环类的一线化学免疫治疗后疾病复发或难治 4. 筛选期根据 Lugano 标准存在 [18F]-氟脱氧葡萄糖 PET/CT 阳性病灶的可测量疾病 5. 美国东部肿瘤协作组（ECOG）体能状态评分为 0 或 1 6. 血液学、肾功能、肝功能、肺功能和心功能充足 主要排除标准： 1. 无资格接受 CD19 CAR T 细胞治疗的患者 2. 原发性中枢神经系统淋巴瘤 3. 原发性皮肤LBCL、人类疱疹病毒-8阳性淋巴瘤、Burkitt淋巴瘤、T细胞富组织细胞淋巴瘤，或由慢性淋巴细胞白血病/小淋巴细胞淋巴瘤转化（Richter转化）的患者 4. 既往有恶性肿瘤病史的患者（侵袭性复发或难治性LBCL除外），除非患者已无病生存≥ 2年 5. 尽管接受了适当的抗生素或其他治疗，仍存在未控制的系统性真菌、细菌、病毒或其他感染（包括结核病）的患者 6. 需要持续全身免疫抑制治疗的活动的自身免疫性疾病。 注：可能适用方案规定的其他纳入/排除标准
Key Inclusion Criteria: 1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy 2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022) * Diffuse large B-cell lymphoma (DLBCL) * Transformations of indolent B-cell lymphomas (excluding Richter's transformation) * DLBCL/High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements * High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS) * Primary mediastinal large B-cell lymphoma (PMBCL) * Grade 3B follicular lymphoma/large cell follicular lymphoma (FL3B) 3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy 4. Measurable disease by presence of \[18F\]-fluorodeoxyglucose PET/CT positive lesion during Screening per Lugano Criteria 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function Key Exclusion Criteria: 1. Patients ineligible to receive CD19 CAR T-cell therapy 2. Primary CNS lymphoma 3. Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter's transformation) 4. Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years 5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment 6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy. Note: Other protocol defined Inclusion/Exclusion criteria may apply
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：Event free survival · The time interval from treatment initiation until the occurrence of a specific event of interest. · 36 months
次要终点：Overall Response Rate；Complete Response Rate；Progression Free Survial；Overall Survival；Incidence and severity adverse events
axicabtagene ciloleucel, lisocabtagene maraleucel
本3期研究比较rondecabtagene autoleucel（ronde-cel，一种靶向CD19/CD20双靶点的CAR-T细胞疗法）与研究者在二线治疗中选择的CD19 CAR-T细胞疗法，用于复发或难治性大B细胞淋巴瘤患者。
This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19/CD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.
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