肿瘤细胞治疗研究
英文原题：A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)
这是一项 I 期注册临床试验，评估细胞治疗用于急性淋巴细胞白血病、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 30 例。试验地点：美国 · 纽约、费城、圣安东尼奥、盐湖城（共 9 个中心）。登记号：NCT06173518。
不限性别 · ≥ 0 Years 且 ≤ 18 Years
纳入标准： • 筛查时年龄<18岁。 • 筛查时体重≥6 kg。 • 儿童复发/难治性B-ALL；或复发/难治性CD19阳性成熟侵袭性B细胞肿瘤，包括DLBCL、Burkitt淋巴瘤、原发性纵隔大B细胞淋巴瘤或高级别B细胞淋巴瘤（未另行分类）。 • Karnofsky评分（年龄≥10岁）或Lansky评分（年龄<10岁）≥50%。 • B-ALL患者须有当地文件记录，证明在知情同意前30天内骨髓、外周血或脑脊液中的白血病原始细胞表达CD19，或活检确认表达。 • 肾、肝、肺和心脏功能充分。 排除标准： • 慢性髓性白血病淋巴母细胞急变。 • 有临床相关CNS病变史或当前病变，且与CNS白血病无关。 • 存在活动性或未控制的真菌、细菌、病毒或其他感染，且需要全身抗菌药物治疗。 • obe-cel输注前3个月内接受过干细胞移植。 • 既往接受除blinatumomab以外的CD19靶向治疗。 • blinatumomab治疗后发生过≥3级神经毒性。
INCLUSION CRITERIA: * \< 18 years old at screening * ≥ 6 kg body weight at screening Pediatric patients with r/r B ALL r/r CD19-positive aggressive mature B including the B NHL subtypes: i) diffuse large B cell lymphoma, ii) Burkitt's lymphoma, iii) primary mediastinal large B cell lymphoma, iv) high-grade B cell lymphoma (not otherwise specified). * Karnofsky (age ≥ 10 years) or Lansky (age \< 10 year) performance status score ≥ 50%. * In participants with B ALL, local documentation of CD19 expression on leukemic blasts in the BM, peripheral blood, or cerebrospinal fluid or biopsy done no more than 30 days prior to consent. * Adequate renal, hepatic, pulmonary, and cardiac function. EXCLUSION CRITERIA: * Diagnosis of chronic myelogenous leukemia in lymphoid blast crisis. * History or presence of clinically relevant central nervous system (CNS) pathology unrelated to CNS leukemia. * Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management. * Received prior (\< 3 months before obe cel infusion) stem cell transplantation. * Prior CD19 targeted therapy other than blinatumomab. * Experienced Grade ≥ 3 neurotoxicity following blinatumomab.
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：Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) · Up to 24 months；Incidence and duration of severe hypogammaglobulinemia · Up to 24 months；Proportion of pediatric participants with r/r B ALL at screening who achieve complete remission (CR) within 3 months of obe-cel infusion per Independent Response Review Committee (IRRC) assessment · 3 months
次要终点：CR per IRRC assessment at any time in B ALL；Overall remission rate (ORR) (CR + complete remission with incomplete recovery of counts [CRi]) per IRRC assessment at any time in B ALL；Minimal residual disease (MRD)-negative ORR per IRRC assessment at any time in B ALL；Event-free survival in B ALL；Overall survival (OS) in B ALL；ORR (CR or partial response [PR]) per Investigator assessment occurring at any time in B NHL；Duration of response in B NHL；Progression-free survival in B NHL
这是一项Ib/II期研究，评估靶向CD19的嵌合抗原受体（CAR）工程化自体T细胞治疗儿童复发/难治性（r/r）B细胞急性淋巴细胞白血病（B-ALL）及复发/难治性B细胞非霍奇金淋巴瘤（B-NHL）的安全性和疗效。
This is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (B ALL) and r/r B cell Non-Hodgkin lymphoma (B NHL).
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