肿瘤细胞治疗研究
英文原题：CD19/ CD22 Bispecific CAR-T Cell Therapy for Relapsed/ Refractory Large B-cell Lymphoma
这是一项 II 期注册临床试验，评估 CD19CAR-T 细胞治疗大 B 细胞淋巴瘤的安全性、可行性及初步疗效。当前状态：进行中（不再招募）。计划入组 100 例。试验地点：中国 · 北京（共 1 个中心，其中中国 1 个）。登记号：NCT07461831。
不限性别 · ≥ 14 Years 且 ≤ 85 Years
纳入标准： • 年龄14至85岁，预期生存期>3个月。 • CD19阳性、伴或不伴CD22阳性的大B细胞淋巴瘤。 • 疾病复发或难治。 • ECOG体能状态评分0至2。 • 至少有一个可测量病灶。 • 心功能分级1至2级。 • 肝功能：总胆红素≤正常值上限的3倍，AST和ALT≤正常值上限的2.5倍。 • 肾功能：肌酐≤正常值上限的1.25倍。 • 骨髓功能：白细胞≥3.0×10^9/L，血红蛋白≥80 g/L，血小板≥50×10^9/L。 • 无严重过敏体质。 • 无与临床方案相冲突的其他严重疾病。 • 无其他癌症史。 • 无严重精神障碍。 • 受试者或其直系亲属已签署知情同意书。 排除标准： • 妊娠或哺乳期女性（有生育能力的女性须血清或尿液妊娠试验阴性）。 • 未控制的活动性感染、HIV感染或梅毒血清学阳性。 • 活动性乙型或丙型肝炎感染。 • 患有严重心、肝、肾功能不全、糖尿病或其他疾病。 • 过去4周内参加过其他临床研究。 • 研究者认为不适合参加研究或可能影响临床试验结果的其他情况。
Inclusion Criteria: * 14 years to 85 years, expected survival \> 3 months; * CD19 positive with or without CD22 positive Large B-cell lymphoma; * relapsed or refractory disease; * ECOG-PS score=0-2; * Having at least one measurable lesion; * Cardiac function: 1-2 levels; * Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; * kidney: Cr≤1.25ULN; * bone marrow: WBC ≥ 3.0×10e9/L, Hb ≥80 g/L, PLT ≥ 50×10e9/L; * No serious allergic constitution; * No other serious diseases that conflicts with the clinical program; * No other cancer history; * No serious mental disorder; * Informed consent is signed by a subject or his lineal relation. Exclusion Criteria: * Pregnant or lactating women (female participants of reproductive potential must have a negative serum or urine pregnancy test); * Uncontrolled active infection, HIV infection, syphilis serology reaction positive; * Active hepatitis B or hepatitis C infection; * With severe cardiac, liver, renal insufficiency, diabetes and other diseases; * Participate in other clinical research in the past 4 weeks; * Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results.
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：best overall response rate (ORR) as of 3 months post-CAR-T cells infusion · Overall response rate means sum of complete response rate and partial response rate · From the day of CAR-T cells infusion to 3 months post-CAR-T cells infusion
次要终点：Best Complete Response rate (CR) as of 3 months post-CAR-T cells infusion；Progression free survival (PFS)；overall survival (OS)；Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
患者接受靶向CD19和CD22的自体CAR-T细胞治疗，双特异性CAR-T细胞剂量为2×10^6/kg。
靶向CD19的CAR-T细胞疗法已被证实可有效治疗经过多线治疗的B细胞急性淋巴细胞白血病或非霍奇金淋巴瘤，但CAR-T治疗后复发仍较常见，CD19抗原丢失是原因之一。因此，研究者认为，CD19/CD22双特异性CAR-T疗法可能疗效更好，并减少B细胞非霍奇金淋巴瘤复发。这项前瞻性II期临床试验旨在探索CD19/CD22双特异性CAR-T治疗复发/难治性大B细胞淋巴瘤的疗效和安全性。
CAR-T cell therapy targeting CD19 has been shown to be effective in heavily-pretreated B-cell ALL or NHL, but relapses post-CAR-T are common, and CD19 antigen loss is one of the reasons. Thus, the investigators supposed that CD19/CD22 bispecific CAR-T cell therapy would be more effective and less relapses would occur in B- NHL. In this prospective phase 2 clinical trial, the investigators aim to explore the efficacy and safety of CD19/CD22 bispecific CAR-T cell therapy in relapsed/refractory Large B cell lymphoma.
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