肿瘤细胞治疗研究
英文原题：CD22/CD19 CAR-T and Auto-HSCT Sandwich Strategy as Consolidation Therapy for B-ALL
这是一项 II 期注册临床试验，评估 CD19CAR-T 细胞治疗急性淋巴细胞白血病的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 37 例。试验地点：中国 · 苏州（共 1 个中心，其中中国 1 个）。登记号：NCT05470777。
不限性别 · ≥ 15 Years 且 ≤ 65 Years
纳入标准： • 原发诊断为B-ALL，且符合以下任一情况：无合适的异基因HSCT供者，或拒绝异基因HSCT。 • 流式细胞术检测外周血或骨髓原始细胞，CD19和CD22均呈阳性表达。 • 超声心动图显示左心室射血分数≥50%；肌酐≤1.6 mg/dL；ALT和AST≤正常范围上限的3倍，总胆红素≤2.0 mg/dL；肺功能：无需吸氧时氧饱和度>91%，呼吸困难≤CTCAE v5.0 1级。 • 年龄15至65岁（含15岁和65岁），性别不限。 • T细胞扩增试验通过。 • 预期生存期>3个月。 排除标准： • 仅发生孤立性髓外病灶复发。 • 合并其他恶性肿瘤。 • 既往接受过抗CD19和/或抗CD22和/或抗CD3治疗。 • 签署知情同意前2周内使用免疫抑制剂，或签署同意后计划使用免疫抑制剂。 • 未控制的活动性感染。 • HIV感染。 • 活动性乙型或丙型肝炎感染。 • 有对氨基糖苷类抗生素发生严重速发型过敏反应史。 • 有临床相关中枢神经系统病变病史或当前存在此类病变，例如癫痫、全面性发作、轻瘫、失语、卒中、严重脑损伤、痴呆、帕金森病、小脑疾病、器质性脑综合征或精神病。
Inclusion Criteria: * subjects with a primary diagnosis of B-ALL who have any of the following: (a) no suitable allogeneic HSCT donor. (b) refusal of allogeneic HSCT. * positive expression of CD19 and CD22 in peripheral blood or bone marrow primary cells detected by flow cytometry. * cardiac ultrasound left ventricular ejection fraction ≥ 50%; Creatinine ≤ 1.6 mg/dl; alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the normal range and total bilirubin ≤ 2.0 mg/dl; Pulmonary function ≤ grade 1 dyspnea (CTCAE v5.0) with oxygen saturation \> 91% without oxygenation. * subjects aged 15-65 years (including 15 and 65 years), regardless of gender. * T-cell amplification test pass. * expected survival \> 3 months. Exclusion Criteria: * patients with recurrence of only isolated extramedullary lesions. * combination of other malignant tumors. * previously treated with anti-CD19 or/and CD22 or/and CD3 therapies. * immunosuppressants use within 2 weeks prior to signing informed consent or plan to immunosuppressants after signing informed consent. * uncontrolled active infections. * HIV infection. * active hepatitis B or hepatitis C infection. * history of severe tachyphylaxis to aminoglycoside antibiotics. * history or presence of clinically relevant Central Nervous System (CNS) pathology, such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
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：Overall survival (OS) · It is measured from the date of the first CAR-T (CAR-T 1) to the date of death from any cause; subjects not known to have died at last follow-up are censored on the date they were last known to be alive · 2 years
次要终点：Leukemia-free survival (LFS)；Measurable residual disease (MRD) negative rate and duration；Incidence of adverse events (AEs)
嵌合抗原受体T细胞（CAR-T）疗法治疗B细胞急性淋巴细胞白血病（B-ALL）已取得显著疗效，但CAR-T后复发仍是主要问题。多抗原CAR-T及其与其他治疗方案联合可能降低复发率。研究者首次在B-ALL患者中采用CD22/CD19 CAR-T与自体HSCT“夹心式”巩固治疗策略。本研究主要观察这一新策略的安全性和疗效。
Chimeric antigen receptor T-cell (CAR-T) therapy has achieved remarkable efficacy in B-cell acute lymphoblastic leukemia (B-ALL). However, relapse after CAR-T has been a major issue. Multi-antigen CAR T and combination with other regimens may reduce the relapse rate. The investigators first conducted CD22/CD19 CAR T-cells and auto-HSCT "sandwich " strategy as consolidation therapy in patients with B-ALL. The main Purpose of this study was to observe the safety and efficacy of this new strategy.
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