Objective: To evaluate the safety and efficacy of C-CAR011 in the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) patients.
Methods: B-NHL patients treated with C-CAR011 infusion following lympho-depletion were enrolled. All the patients were followed up for 1 year after C-CAR011 treatment(5.0×106 /kg). The primary endpoint of this research was safety; and the secondary endpoints included objective response rate (ORR), progression-free survival (PFS), duration of overall response (DOR), overall survival (OS) at Week 4, 12 and Month 6 and 12.
Results: The ratio of the male and female of 6 patients was 1∶1, and the patients were treated with C-CAR011 at a dose of 5.0×106 /kg. The median age was 46.5 years old (37-62 years); 5 patients were diagnosed as diffuse large b-cell lymphoma (DLBCL) and 1 patient was diagnosed as follicular lymphoma (FL). The most common adverse events (AEs) were hematological toxicities (100%, Grade 3-4), cytokine release syndrome (CRS) (66.7%, Grade 1-3), neurotoxicity (16.7%, Grade 3). All these AEs were reversible and could be conversed. The ORR at Week 4, 12 and Month 6, 12 were 50%(3/6), 50%(3/6), 16.7%(1/6) and 16.7%(1/6), respectively. Three patients (50%) achieved complete response (CR) and one of them stayed evaluated as CR until Month 12. The median PFS was 178 days (91->365 days). For 3 patients with response, the DOR were 150 days, 154 days and >12 months, respectively. The OS rates of the patients at Week 12, Month 6, 12 were 100%, 100%, 83.3%, respectively, while the median OS was not reached.
Conclusion: C-CAR011 is a safe treatment option for R/R B-NHL; some patients could achieve long-term sustained responses after C-CAR011 infusion（ClinicalTiral.gov number, NCT03483688）.
题目: 靶向CD19嵌合抗原受体T细胞（C-CAR011）治疗复发难治B细胞非霍奇金淋巴瘤.
目的: 评价靶向CD19嵌合抗原受体T细胞注射液C-CAR011治疗复发或难治性B细胞非霍奇金淋巴瘤（R/R B-NHL）患者的安全性和有效性.
方法: 入选的R/R B-NHL患者，予淋巴细胞清除术及CD19 CART输注治疗（C-CAR011 5.0×106 /kg）后，随访至CD19 CART治疗后1年。主要研究终点是安全性；次要研究终点包括第4周、12周、6个月与12个月患者的总缓解率（ORR）、无疾病进展（PFS）、缓解持续时间（DOR）的情况，以及第12周、第6和12个月的总生存期（OS）.
结果: 6例R/R B-NHL受试者接受C-CAR011治疗及随访，中位年龄为46.5（37-62）岁，男女比例为1∶1，5例患者为弥漫大B细胞淋巴瘤（DLBCL），1例患者为滤泡淋巴瘤（FL）。治疗后主要不良反应为血液学毒性（发生率100%，均为3-4级），细胞因子释放综合征（CRS）（发生率66.7%，1-3级），神经毒性（发生率16.7%，3级），均可控且可逆。在4、12周和6、12个月获得OR的患者分别有3例、3例、1例和1例，有3例患者最佳疗效为完全缓解（CR），其中1例在1年评估时仍保持CR。中位PFS为178（91->365）d。曾经获得缓解的3例患者的DOR分别为150、154 d 和12个月以上。患者的OS率在第12周、6个月和12个月时分别为100%、100%和83.3%，而中位OS未达到.
结论: C-CAR011可安全的用于R/R B-NHL，且可在部分患者中获得长期持续疗效（研究注册号：NCT03483688）.