肿瘤细胞治疗研究
英文原题：Administration of Anti Tim-3/CD123 CAR-T Cell Therapy in Relapsed and Refractory Acute Myeloid Leukemia (rr/AML)
⚠ 该试验的登记信息已有 35 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 20 例。试验地点：中国 · 徐州（共 1 个中心，其中中国 1 个）。登记号：NCT06125652。
不限性别 · ≥ 18 Years 且 ≤ 70 Years
纳入标准：受试者须在任何研究特定程序或活动开始前签署并注明日期的知情同意书；年龄18-70岁；确诊复发/难治性（r/r）新发或继发性急性髓系白血病（AML）；既往治疗毒性已恢复；ECOG≤2分且预期生存期≥3个月；器官功能充分：AST≤正常值上限（ULN）3倍、ALT≤ULN 3倍、总胆红素≤ULN 1.5倍、血清肌酐≤ULN 1.5倍或肌酐清除率（CCR）≥60 mL/min、血红蛋白≥60 g/L、室内空气血氧饱和度≥92%、LVEF≥45%；有生育能力女性血清或尿妊娠试验阴性；男性及有生育能力女性同意从使用研究药物至治疗后2年采取有效避孕措施。排除标准：急性早幼粒细胞白血病；CNS疾病史或当前CNS疾病；HBsAg阳性，HCV/HIV/梅毒抗体阳性，或外周血CMV DNA≥500 copies/mL；严重过敏反应史；入组前12个月内心肌梗死、心脏血管成形术或支架置入、不稳定型心绞痛、纽约心脏协会II级及以上充血性心衰、房颤或其他有临床意义心脏病史；器官移植史；需要全身免疫抑制剂或其他药物治疗；入组前3个月内自体干细胞移植；活动性自身免疫病或神经系统炎症性疾病（如格林-巴利综合征、肌萎缩侧索硬化）及临床活动性脑血管疾病（如脑水肿、可逆性后部脑病综合征）；因正在发生或即将发生的肿瘤急症需紧急治疗（如白细胞淤滞或肿瘤溶解综合征）；存在未控制或需抗微生物药物治疗的真菌、细菌、病毒或其他感染；入组前≤4周接种活疫苗；严重精神疾病；入组前4周内接受大型手术；酗酒或药物滥用史；研究者认为不适合参加研究。
Inclusion Criteria: 1. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities; 2. At the age of 18-70 years old; 3. Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML); 4. The patient has recovered from the toxicity of previous treatment; 5. ECOG score ≤ 2 and expected survival period is not less than 3 months; 6. Adequate organ function defined as:AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%; 7. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test; 8. From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception. Exclusion Criteria: 1. Diagnosis of acute promyelocytic leukemia; 2. History or presence of a CNS disorder; 3. HBsAg is positive; HCV #HIV or Syphilis antibody are positive, CMV-DNA in peripheral blood is more than≥500 copies /mL; 4. History of severe hypersensitivity reaction; 5. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment; 6. History of organ transplant surgery; 7. Required systemic application of immunosuppressive or other drugs; 8. Auto-SCT within the 3 months before enrollment; 9. Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES)); 10. Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ; 11. Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management; 12. Live vaccine received within the ≤ 4 weeks before enrollment; 13. Persons with serious mental illness; 14. History of major surgical operations four weeks before enrollment; 15. History of alcoholism or substance abuse; 16. Was identified by the investigators as unsuitable to participate in the study.
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：Dose-limiting toxicity #DLT# · Adverse events assessed according to NCI-CTCAE v5.0 · Baseline up to 28 days after CAR-T cells infusion
次要终点：MRD negative overall response rate (MRD- ORR)；Overall response rate (ORR)；Event-free survival (EFS)；Overall survival (OS)
入组患者将接受预先规定剂量的自体CAR-T细胞。
本研究旨在评估抗Tim-3/CD123 CAR-T细胞治疗复发和难治性急性髓系白血病的安全性和疗效。
To evaluate the safety and efficacy of anti Tim3/CD123 CAR-T cells in the treatment of relapsed and refractory acute myeloid leukemia.
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