Department of Hematology, Peking University First Hospital, Beijing, China.
Hematol Oncol. 2020 Aug;38(3):272-276. doi: 10.1002/hon.2726. Epub 2020 Mar 3.
The efficacy and safety of Epstein-Barr virus (EBV)-specific antigen peptide-activated cytotoxic T lymphocytes (CTLs) in the treatment of refractory or recurrent angioimmunoblastic T-cell lymphoma (AITL) was determined in this prospective one-arm clinical study. Seven males and two females were enrolled with a median age of 70 years. The tumor stages were all stage III and IV. All patients had group B symptoms and IPI scores of 3 to 5 points. All patients received chemotherapy before CTLs infusion which the median chemotherapy cycle was three. The diseases states before CTLs included five cases of disease progression (PD), two cases of recurrence (R), and two cases with residual lesions after chemotherapy. Eight patients received HLA-haploidentical EBV-specific CTLs, and one patient chose autologous CTLs. The number of transfused cells was 1.67 to 2.38 × 10 for one course of CTLs therapy. One patient was treated with three courses of CTLs, three patients were treated with two courses of CTLs, and five patients were treated with one course of CTLs. During the infusion, eight patients had fever, one patient had rash, and no graft-vs-host diseases were observed. The EBV-DNA decreased by more than two orders of magnitude in six patients, and the response rate was 66.7%. Two patients of PD status achieved complete remission (CR), one patient of PD status achieved partial remission, two patients with residual lesions after chemotherapy achieved CR, and four patients had no response. The objective remission rate was 55.6%. After the median follow-up of 14.5 months, five patients died, and three patients were completely relieved while one patient was lost during follow-up. The 3-year overall survival was 44.4% and 3-year progression-free survival was 33.3%. EBV-specific antigen peptide-activated CTLs showed positive effect in certain patients with refractory and recurrent AITL with high clinical safety.
本前瞻性单臂临床研究旨在确定 EBV 特异性抗原肽激活的细胞毒性 T 淋巴细胞（CTL）在治疗难治性或复发性血管免疫母细胞性 T 细胞淋巴瘤（AITL）中的疗效和安全性。纳入 7 名男性和 2 名女性，中位年龄为 70 岁。所有患者均为 III 期和 IV 期。所有患者均有 B 组症状和 IPI 评分为 3 至 5 分。所有患者在 CTL 输注前均接受化疗，化疗周期中位数为 3 个周期。CTL 输注前疾病状态包括 5 例疾病进展（PD）、2 例复发（R）和 2 例化疗后残留病灶。8 例患者接受 HLA 单倍体 EBV 特异性 CTL，1 例患者选择自体 CTL。一个疗程 CTL 治疗输注的细胞数为 1.67 至 2.38×10。1 例患者接受了 3 个疗程的 CTL，3 例患者接受了 2 个疗程的 CTL，5 例患者接受了 1 个疗程的 CTL。输注期间，8 例患者发热，1 例患者皮疹，未观察到移植物抗宿主病。6 例患者 EBV-DNA 下降超过两个数量级，反应率为 66.7%。2 例 PD 状态患者达到完全缓解（CR），1 例 PD 状态患者达到部分缓解，2 例化疗后残留病灶患者达到 CR，4 例患者无反应。客观缓解率为 55.6%。中位随访 14.5 个月后，5 例患者死亡，3 例患者完全缓解，1 例患者失访。3 年总生存率为 44.4%，3 年无进展生存率为 33.3%。EBV 特异性抗原肽激活的 CTL 在某些难治性和复发性 AITL 患者中显示出积极的疗效，且具有较高的临床安全性。
