肿瘤细胞治疗研究
英文原题：Off-the-shelf CD123 CAR-NK for R/R AML
⚠ 该试验的登记信息已有 19 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。
这是一项早期 I 期注册临床试验，评估细胞治疗用于急性髓系白血病的安全性、可行性及初步疗效。当前状态：招募中。计划入组 12 例。试验地点：中国 · 北京（共 1 个中心，其中中国 1 个）。登记号：NCT06201247。
不限性别 · ≥ 18 Years
纳入标准： 1. 年龄≥18岁，性别和种族不限。 2. 预期生存期≥3个月。 3. ECOG体能状态评分0～2分。 4. 经骨髓活检、免疫组化或流式细胞术确诊为CD123阳性AML，并符合以下情况： A. 复发AML诊断标准：完全缓解（CR）后外周血再次出现白血病细胞，或骨髓原始细胞≥5%（巩固化疗后骨髓再生等其他原因除外），或出现髓外白血病细胞浸润。 B. 难治性AML诊断标准：初治患者接受2个疗程标准方案后无效；达到CR后接受巩固／强化治疗但12个月内复发；12个月后复发但常规化疗无效；复发≥2次；髓外白血病持续存在；或异基因造血干细胞移植（allo-HSCT）后复发。 C. 仅微小残留病（MRD）阳性或复发：治疗资格评估时骨髓穿刺（BMA）经多参数流式细胞术（MFC）评估为MRD阳性。 5. 器官功能充足： A. 肝功能：ALT≤正常值上限（ULN）的3倍，AST≤ULN的3倍，总胆红素≤ULN的2倍。 B. 凝血功能：国际标准化比值（INR）或活化部分凝血活酶时间（APTT）≤ULN的1.5倍。 C. 肾功能：血清肌酐≤ULN的1.5倍，或肌酐清除率≥30 mL/min。 D. 心功能：左心室射血分数（LVEF）≥50%。 6. 有生育能力的女性及所有男性受试者须在输注后至少12个月内采取有效避孕措施。 7. 知情同意／同意参加：所有受试者均须能够理解并愿意签署书面知情同意书。 排除标准： 1. 活动性中枢神经系统白血病。 2. 对方案规定的氟达拉滨／环磷酰胺淋巴细胞清除化疗有已知禁忌证。 3. 入组前4周内全身使用激素（吸入性糖皮质激素除外）。 4. 首次研究药物给药前14天内存在任何需要静脉全身治疗的活动性感染，包括HBV、HCV、HIV、梅毒感染或活动性肺结核。 5. 对含鼠源蛋白产品或抗体、细胞因子等大分子生物制剂有超敏反应史。 6. 无法保证入组后1年内有效避孕（如使用避孕套或避孕药等）。 7. 妊娠试验（尿液／血液）阳性的女性或哺乳期女性。 8. 患有严重自身免疫性疾病或免疫缺陷病。 9. 患有精神疾病。 10. 已知酒精依赖或药物依赖。 11. 研究者判断患者存在其他不适合入组的情况。
Inclusion criteria: 1. Age ≥ 18 years old, no gender or race; 2. Expected survival period ≥ 3 months; 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; 4. The diagnosis of AML with bone marrow biopsy, immunohistochemistry or Flow cytometry definitively positive for CD123 and met the following criteria: A. Diagnostic criteria for relapsed AML: after complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration; B. Diagnostic criteria for refractory AML: naive patients who were ineffective after 2 courses of standard regimens; patients relapsed within 12 months who underwent consolidation and intensive therapy after CR; patients relapsed after 12 months but were ineffective after conventional chemotherapy; Patients with two or more relapses; patients with persistent extramedullary leukemia; Patients relapsed after allogeneic hematopoietic stem cell transplantation (allo-HSCT) C. Minimal Residual Disease (MRD) positive only or relapse: Patient is minimal residual disease (MRD) positive, as assessed on bone marrow aspirate (BMA) by Multiparameter Flow Cytometry (MFC) at time of Treatment Eligibility assessment. 5. Adequate organ function: A. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL/min; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; 6. Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.; 7. Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: 1. Active Central nervous system leukemia; 2. Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide; 3. Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids); 4. Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis. 5. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines; 6. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment; 7. Women who are pregnant (urine/blood pregnancy test positive) or lactating; 8. Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness; 10\. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions. \-
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：1-month DLTs · Dose limiting toxicities (DLTs) · 1-month
次要终点：3-month CR/CRi；1-year PFS；1-year OS；1-year MRD(-)；3-month AUC；3-month Peak
复发／难治性AML患者在接受氟达拉滨／环磷酰胺（FC）化疗后，接受最多3个剂量水平的JD123注射液：5.0×10⁸、1.5×10⁹或3.0×10⁹个细胞／剂。
这是一项单中心、单臂、开放标签、首次人体研究，旨在评估靶向CD123的通用现货型CAR-NK细胞（JD123注射液）治疗复发或难治性CD123阳性急性髓系白血病（AML）的安全性、耐受性和初步疗效。
This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (AML).
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