肿瘤细胞治疗研究
英文原题：Study of T Cells Targeting CD138/BCMA/CD19/More Antigens (CART-138/BCMA/19/More) for Chemotherapy Refractory and Relapsed Multiple Myeloma
⚠ 该试验的登记信息已有 90 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 I/II 期注册临床试验，评估 BCMA 细胞治疗用于多发性骨髓瘤的安全性、可行性及初步疗效。当前状态：招募中。计划入组 10 例。试验地点：中国 · 苏州（共 1 个中心，其中中国 1 个）。登记号：NCT03196414。
不限性别 · ≥ 18 Years 且 ≤ 75 Years · 接受健康志愿者
纳入标准： • 多发性骨髓瘤细胞表达 CD138 或 BCMA，且无可用的根治性治疗选择（如自体或异基因造血干细胞移植）。 • 复发和/或难治性多发性骨髓瘤。 • 既往自体或异基因造血干细胞移植后复发。 • 预期生存期≥3个月。 • 肌酐<2.0 mg/dL。 • 凝血功能：PT 和 APTT<正常值的2倍。 • 动脉血氧饱和度>92%。 • ALT/AST<正常值的3倍。 • Karnofsky 评分≥60且 ECOG 评分≤2。 • 有适合单采的静脉通路，且无其他白细胞单采禁忌证。 • CAR-T 输注前1个月内不接受系统性化疗，前3个月内不接受免疫治疗。 • 自愿签署知情同意书。 排除标准： • 妊娠或哺乳期女性。 • 未控制的活动性感染。 • 活动性乙型或丙型肝炎感染。 • 同时使用全身性类固醇（近期或当前吸入性类固醇不排除）。 • 既往接受过任何基因治疗产品。 • 任何妨碍参加研究的未控制活动性疾病。 • HIV 感染。 • 过去6个月内发生心肌梗死或严重心律失常。 • 任何形式的原发性免疫缺陷（如重症联合免疫缺陷病）。 • 不明原因发热（体温>38°C）。
Inclusion Criteria: * CD138 or BCMA antigen positive multiple myeloma in patients with no available curative treatment options (such as autologous or allogeneic SCT). * Relapsed and/or refractory multiple myeloma. * Relapsed after prior autologous or allogenic SCT. * Expected survival ≥ 3 months * Creatinine \< 2.0 mg/dl * Blood coagulation function: PT and APTT \< 2x normal * Arterial blood oxygen saturation \> 92% * Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) \< 3x normal * Karnofsky scores ≥ 60 and ECOG score ≤ 2 * Adequate venous access for apheresis, and no other contraindications for leukapheresis * Patients should not take system chemotherapy in one month and immunotherapy in three months prior to CART cells infusion. * Voluntary informed consent is given Exclusion Criteria: * Pregnant or lactating women * Uncontrolled active infection. * Active hepatitis B or hepatitis C infection. * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. * Previously treatment with any gene therapy products * Any uncontrolled active medical disorder that would preclude participation as outlined. * HIV infection. * History of myocardial infarction and severe arrhythmia in half a year * Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). * Patients with fever of unknown origin (T \> 38℃)
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：Determine if there is grade 3 to 5 cytokine release syndrome · Number of Patients With Grade 3 Through Grade 5 Cytokine Release Syndrome(CRS) That Are Related to Study Intervening Measures, Graded According to NCI CTCAE Version 4.0 · 2 weeks-12 months after initial dose
次要终点：Investigators try to assess major reaction rate (MRR, PR+VGPR+CR) at the end of the research.
在患者自体或供者来源 T 细胞中导入实验室构建的肿瘤抗原嵌合受体，可能诱导机体免疫反应并杀伤癌细胞。基因工程淋巴细胞（CAR-T）治疗已在淋巴瘤和急性淋巴细胞白血病中显示出良好的安全性和疗效。本研究评估靶向 CD138、B 细胞成熟抗原（BCMA）、CD19 或其他抗原的 T 细胞治疗化疗难治或复发性多发性骨髓瘤的安全性和疗效；包括造血干细胞移植或强化化疗后复发者。
Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous or donor-derived T cells may make the body build immune response to kill cancer cells. Genetically engineered lymphocyte (CART) therapy has showed good safety and efficacy in treatment of lymphoma and acute lymphoblastic leukemia. Researchers want to see if this helps people with multiple myeloma.To test the safety and efficacy of giving targeting CD138 or B-cell maturation antigen or CD19 or more antigens T cells in treating patients with multiple myeloma that is refractory to further chemotherapy or relapsed(after stem cell transplantation or intensive chemotherapy).
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