肿瘤细胞治疗研究
英文原题：Phase I/II Open-label Study Evaluating The Safety And Efficacy of Concomitant Administration of Anti-CD19 CAR T-cell Therapy and Lenalidomide in Refractory/Relapsed Chronic Lymphocytic Leukemia Patients.
这是一项 I/II 期注册临床试验，评估细胞治疗用于慢性淋巴细胞白血病、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 24 例。试验地点：其他 · 维捷布斯克（共 1 个中心）。登记号：NCT06762431。
不限性别 · ≥ 18 Years
纳入标准：确诊CD19阳性CLL或小淋巴细胞淋巴瘤（SLL）；至少1种既往方案治疗失败；入组前目前接受伊布替尼至少3个月，且无≥2级非血液学伊布替尼相关毒性；ECOG体能状态0–1；年龄≥18岁；器官功能充分：肌酐<1.6 mg/dL、ALT/AST<正常值上限3倍、总胆红素<2.0 mg/dL（Gilbert综合征患者例外；原文标准表述为总胆红素≥3.0×ULN且直接胆红素≤1.5×ULN）；无活动性GVHD且不需免疫抑制；移植后>6个月；无白细胞单采禁忌；LVEF>50%；签署知情同意书。 排除标准：已知或疑似转化性CLL（如Richter转化）；妊娠或哺乳；未控制的活动性感染；活动性乙肝或丙肝；同时使用全身性类固醇或长期使用免疫抑制药物；任何未控制的活动性疾病；HIV感染；恶性肿瘤活动性中枢神经系统受累；NYHA III/IV级心血管功能障碍；有临床症状的心律失常或不稳定心律失常。
Inclusion Criteria: * Documented CD19+ CLL or SLL * Patients must have failed at least 1 prior regimen * Patients must be currently receiving ibrutinib for at least 3 months prior to enrollment in the study and: * Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity * ECOG Performance status 0 or 1 * 18 years of age and older * Adequate organ system function including: Creatinine \< 1.6 mg/dl ALT/AST \< 3x upper limit of normal Total Bilirubin \<2.0 mg/dl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ≥ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN. * Have no active GVHD and require no immunosuppression * Are more than 6 months from transplant * No contraindications for leukapheresis * Left Ventricular Ejection fraction \>50% * Gives informed consent Exclusion Criteria: * CLL patients with known or suspected transformed disease (i.e. Richter's transformation). * Pregnant or lactating women. * Uncontrolled active infection. * Active hepatitis B or hepatitis C infection. * Concurrent use of systemic steroids or chronic use of immunosuppressant medications. * Any uncontrolled active medical disorder * HIV infection. * Patients with active CNS involvement with malignancy. * Class III/IV cardiovascular disability according to the New York Heart Association Classification. * Subjects with clinically apparent arrhythmia or arrhythmias who are not stable
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：Adverse events incidence · 24 months；Safety · * To preliminarily explore the safety (incidence of CRS, ICANS, HLH, infections, late ICAHT, and cytopenias) and tolerability.
* To explore the pharmacokinetics of CAR-T cells. · 24 months
次要终点：Efficacy
I期：确定IL-7/IL-15扩增的25×10^6个抗CD19 CAR-T细胞联合来那度胺的安全性；来那度胺10 mg口服，第0–6天。采用3+3设计，每队列3人。第28天，MRD阳性患者可接受来那度胺10 mg口服（第1–14天）联合奥妥珠单抗1000 mg静脉给药（第1周期第1、8、15天，以及第2–6周期第1天）巩固；MRD阴性患者接受来那度胺10 mg口服（第1–14天）维持3个周期。
I期：确定IL-7/IL-15扩增的50×10^6个抗CD19 CAR-T细胞联合来那度胺的安全性；来那度胺10 mg口服，第0–6天。采用3+3设计。第28天后MRD阳性者可接受来那度胺10 mg口服（第1–14天）联合奥妥珠单抗1000 mg静脉给药（第1周期第1、8、15天，以及第2–6周期第1天）巩固；MRD阴性者接受来那度胺10 mg口服（第1–14天）维持3个周期。每队列3人。
I期：确定IL-7/IL-15扩增的100×10^6个抗CD19 CAR-T细胞联合来那度胺的安全性；来那度胺10 mg口服，第0–6天。采用3+3设计。第28天后MRD阳性者可接受来那度胺10 mg口服（第1–14天）联合奥妥珠单抗1000 mg静脉给药（第1周期第1、8、15天，以及第2–6周期第1天）巩固；MRD阴性者接受来那度胺10 mg口服（第1–14天）维持3个周期。每队列9人。
这是一项I/II期干预性开放标签治疗研究，评估抗CD19 CAR-T细胞联合来那度胺治疗成人复发/难治性慢性淋巴细胞白血病（CLL）的安全性和疗效。患者在白细胞单采前须已接受伊布替尼治疗至少3个月。
This is a Phase I/II interventional, open-label treatment study designed to evaluate the safety and efficacy of concomitant therapy with anti-CD19 CAR T-cells and Lenalidomide in adult patients with relapsed/refractory chronic lymphocytic leukemia (CLL) who have been pretreated with Ibrutinib for 3 months prior to leukapheresis.
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