肿瘤细胞治疗研究
英文原题：Ex Vivo T-Cell-Depleted Haploidentical Transplantation Bridging With Chimeric Antigen Receptor T-cell Therapy and Prophylactic Memory T Cell Infusion for Acute Leukemia
Ex Vivo T-Cell-Depleted Haploidentical Transplantation Bridging With Chimeric Antigen Receptor T-cell Therapy and Prophylactic Memory T Cell Infusion for Acute Leukemia
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⚠ 该试验的登记信息已有 14 个月未更新， 页面上显示的「尚未开始招募」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。
这是一项分期未标注的注册临床试验，评估造血干细胞治疗白血病、急性髓系白血病的安全性、可行性及初步疗效。当前状态：尚未开始招募。计划入组 18 例。试验地点：中国 · 上海（共 1 个中心，其中中国 1 个）。登记号：NCT07087847。
不限性别 · ≥ 18 Years
纳入标准：确诊复发/难治性白血病；通过HLA分型未找到匹配的同胞或无关供者；CAR-T 治疗后疾病状态符合方案要求，包括达到完全缓解、骨髓微小残留病（MRD）阴性且无髓外复发；器官功能正常：ALT/AST≤正常值上限（ULN）10倍，总胆红素≤ULN 5倍，血尿素氮（BUN）和血清肌酐≤ULN 1.25倍，心电图和超声心动图未提示心功能不全；已签署知情同意书。排除标准：存在造血干细胞移植的绝对禁忌证；伴有导致重要器官功能障碍的严重合并症。
Inclusion Criteria: * Diagnosis: Patients with refractory or relapsed (R/R) leukemia. * Donor Availability: No matched sibling or unrelated donor identified through HLA typing. * Disease Status Post-CAR-T: including achieved complete remission (CR), minimal residual disease (MRD)-negative in bone marrow and no extramedullary relapse. * Normal Organ Function (meeting the following criteria): including liver function: ALT/AST ≤10×ULN (upper limit of normal), total bilirubin (TBIL) ≤5×ULN, renal function: BUN and serum creatinine (Cr) ≤1.25×ULN and cardiac function: No evidence of cardiac insufficiency (confirmed by ECG and echocardiography). * Informed Consent: a signed informed consent form (ICF) is obtained Exclusion Criteria: * Presence of any absolute contraindication to hematopoietic stem cell transplantation. * Severe Comorbidities with Major Organ Dysfunction
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：2-Year Event-Free Survival (EFS) Rate · Definition: The proportion of patients who remain free from any of the following events for 2 years post-transplantation · 2 years
对于复发/难治性白血病患者，CAR-T 治疗后约28天进行血液学评估。符合纳入标准者随后接受去除TCRαβ+/CD45RA+细胞的半相合造血干细胞移植（haplo-HSCT）。
CAR-T 疗法已成为复发/难治性白血病的重要治疗手段，可提高缓解率且不良事件通常可控。但超过50%的完全缓解患者会在一年内复发，可能与抗原逃逸、CAR-T 功能耗竭、细胞过早清除及免疫抑制微环境有关，因此亟需维持持久缓解的新策略。CAR-T 治疗后桥接体外去除TCRαβ+及CD45RA+细胞的半相合造血干细胞移植（HSCT），具有双重潜在获益：供者来源NK细胞及γδT细胞介导的移植物抗白血病（GvL）作用可靶向非CAR相关抗原、减少免疫逃逸；快速重建造血可减少既往治疗所致长期血细胞减少并发症。本方案还预防性输注CD45RO+记忆T细胞（Tm），以降低相较常规供者淋巴细胞输注（DLI）的GVHD风险，并通过转移供者记忆免疫增强抗感染和抗复发能力。本前瞻性单中心单臂试验将在CAR-T 治疗后的复发/难治性白血病患者中，使用CliniMACS®系统体外去除TCRαβ+/CD45RA+细胞，评估该策略的疗效和安全性。
CAR-T therapy has evolved as a pivotal treatment for relapsed/refractory (R/R) leukemia, demonstrating improved remission rates and manageable adverse events. However, over 50% of patients achieving complete remission (CR) experience relapse within one year (1-year cumulative incidence rate, CIR) due to antigen escape, CAR-T functional exhaustion, premature cell depletion, and immunosuppressive microenvironments. Novel strategies are urgently needed to sustain durable responses. Bridging CAR-T therapy with TCRαβ+ and CD45RA+ cell-depleted haploidentical hematopoietic stem cell transplantation (HSCT) offers dual benefits: Graft-versus-leukemia (GvL) effects mediated by donor-derived NK cells and γδT cells target non-CAR-dependent antigens, mitigating immune evasion. Rapid hematopoietic reconstitution reduces prolonged cytopenia-related complications from prior therapies. This protocol further incorporates prophylactic CD45RO+ memory T-cell (Tm) infusion to: Minimize graft-versus-host disease (GVHD) risks compared to conventional donor lymphocyte infusion (DLI). Enhance adoptive immunity against infections/relapse via transferred donor memory immunity. We design this prospective, single-center, single-arm trial to evaluate the efficacy/safety of this approach using the CliniMACS® system for ex vivo TCRαβ+/CD45RA+ depletion in R/R leukemia patients post-CAR-T.
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