肿瘤细胞治疗研究
英文原题：Clinical Study of ARD103 CAR-T Therapy for Patients With R/R AML or MDS
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、骨髓增生异常综合征的安全性、可行性及初步疗效。当前状态：招募中。计划入组 49 例。试验地点：美国 · 夏洛特、温斯顿-塞勒姆、休斯顿（共 3 个中心）。登记号：NCT06680752。
不限性别 · ≥ 18 Years
纳入标准： • 有文件记录确诊AML且为难治/复发，或确诊MDS且骨髓原始细胞≥5%。 • ECOG体能状态评分0或1。 • 血液学指标充分：绝对淋巴细胞计数（ALC）>100/mm³。 • 肾、肝、心脏及肺功能充分：ALT和AST<ULN的3.0倍；按Cockcroft-Gault公式估算肌酐清除率≥45.0 mL/min且不依赖透析；总胆红素≤2.0 mg/dL。 • 有生育可能的女性妊娠检测（血清或尿液）须为阴性。 • 有生育可能的男性和女性须同意使用有效避孕方法。 • 参加者能够签署知情同意。 排除标准： • 急性早幼粒细胞白血病。 • 存在活动性且有临床意义的中枢神经系统（CNS）疾病。 • 自身免疫性疾病且需要免疫抑制治疗。 • 已知肝桥接纤维化/肝硬化。 • 活动性乙型或丙型肝炎感染。 • 既往接受研究性基因或细胞治疗（包括CAR治疗）。 • 存在活动性急性GVHD，或每天接受超过10 mg泼尼松（或等效剂量）的全身治疗。 • 筛查前14天内接受针对本病的化疗（包括生物/靶向治疗或免疫治疗），且研究期间亦不得接受此类治疗。
Inclusion Criteria: * Documented diagnosis of AML with either refractory or relapsed disease or diagnosis of MDS and ≥ 5% BM blasts * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate hematologic status: * Absolute lymphocyte count (ALC) \> 100/mm3 * Adequate renal, hepatic, cardiac and pulmonary function: * ALT and AST \< 3.0 × the ULN * Creatinine clearance ≥ 45.0 mL/min as estimated by Cockcroft-Gault and independent dialysis * Total bilirubin ≤ 2.0 mg/dL * Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test * Contraception: males and females of childbearing potential must agree to use an effective method of contraception * Participant is capable of giving signed informed consent Exclusion Criteria: * Participants with acute promyelocytic leukemia * Presence of active and clinically relevant central nervous system (CNS) disorder * Autoimmune disease requiring immunosuppressive treatment * Participants with known hepatic bridging cirrhosis * Currently active infection with hepatitis B or C * Previous treatment with investigational gene or cell therapy (including CAR therapy) * Any active acute GvHD or systemic treatment of more than 10 mg prednisone daily (or equivalent) * Previous chemotherapy including biologic/targeted therapy or immunological agents directed to the pathology within 14 days prior to screening and all along the study duration
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：Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] · The records of AEs and severity following the first infusion of ARD103. · 28 days post ARD103 infusion；To determine the RP2D of ARD103 · RP2D of ARD103 following a 3+3 dose escalation schema (Phase 1) · 28 days post ARD103 infusion；To evaluate overall response rate (ORR) · The ORR will be evaluated by European Leukemia Net (ELN) criteria · Up to 24 months
次要终点：Overall Survival (OS)；Progression-free survival (PFS)；Time to best response
I期采用3+3设计测试3个递增剂量水平，确定最大耐受剂量（MTD）和RP2D。II期分两阶段开展：第一阶段纳入I期按RP2D治疗且可评估的参加者；第二阶段继续增加可评估参加者，以RP2D评估初步疗效和安全性。
这是一项I/II期、干预性、开放标签、多中心研究，评估ARD103治疗复发或难治性急性髓系白血病或骨髓增生异常综合征患者的安全性和疗效。
This is a phase I/2, interventional, open-label, multicenter study to assess the safety and efficacy of ARD103 in patients with relapsed or refractory acute myeloid leukemia or myelodysplastic syndrome.
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