嵌合抗原受体T细胞治疗难治性B细胞淋巴瘤
Chimeric Antigen Receptor T Cells in Refractory B-Cell Lymphomas
对免疫化疗和移植后仍复发或难治的弥漫大B细胞淋巴瘤和滤泡性淋巴瘤患者，预后很差，此前CAR-T治疗B细胞淋巴瘤的数据有限。这项研究用自体CD19 CAR-T细胞（CTL019）治疗28例成人患者。18例（64%）出现缓解：弥漫大B细胞淋巴瘤14例中6例完全缓解（43%），滤泡性淋巴瘤14例中10例完全缓解（71%）。中位随访28.6个月时，多数有缓解者维持缓解。5例（18%）发生严重细胞因子释放综合征，3例（11%）发生严重脑病，其中1例死亡。结果支持CTL019对这类淋巴瘤有效，但需警惕神经和炎症毒性。
为什么推荐给您：CD19 CAR-T治疗B细胞淋巴瘤的早期人体阳性结果，建立了持久缓解证据。
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摘要Abstract
BACKGROUND: Patients with diffuse large B-cell lymphoma or follicular lymphoma that is refractory to or that relapses after immunochemotherapy and transplantation have a poor prognosis. High response rates have been reported with the use of T cells modified by chimeric antigen receptor (CAR) that target CD19 in B-cell cancers, although data regarding B-cell lymphomas are limited.
METHODS: We used autologous T cells that express a CD19-directed CAR (CTL019) to treat patients with diffuse large B-cell lymphoma or follicular lymphoma that had relapsed or was refractory to previous treatments. Patients were monitored for response to treatment, toxic effects, the expansion and persistence of CTL019 cells in vivo, and immune recovery.
RESULTS: A total of 28 adult patients with lymphoma received CTL019 cells, and 18 of 28 had a response (64%; 95% confidence interval [CI], 44 to 81). Complete remission occurred in 6 of 14 patients with diffuse large B-cell lymphoma (43%; 95% CI, 18 to 71) and 10 of 14 patients with follicular lymphoma (71%; 95% CI, 42 to 92). CTL019 cells proliferated in vivo and were detectable in the blood and bone marrow of patients who had a response and patients who did not have a response. Sustained remissions were achieved, and at a median follow-up of 28.6 months, 86% of patients with diffuse large B-cell lymphoma who had a response (95% CI, 33 to 98) and 89% of patients with follicular lymphoma who had a response (95% CI, 43 to 98) had maintained the response. Severe cytokine-release syndrome occurred in 5 patients (18%). Serious encephalopathy occurred in 3 patients (11%); 2 cases were self-limiting and 1 case was fatal. All patients in complete remission by 6 months remained in remission at 7.7 to 37.9 months (median, 29.3 months) after induction, with a sustained reappearance of B cells in 8 of 16 patients and with improvement in levels of IgG in 4 of 10 patients and of IgM in 6 of 10 patients at 6 months or later and in levels of IgA in 3 of 10 patients at 18 months or later.
CONCLUSIONS: CTL019 cells can be effective in the treatment of relapsed or refractory diffuse large B-cell lymphoma and follicular lymphoma. High rates of durable remission were observed, with recovery of B cells and immunoglobulins in some patients. Transient encephalopathy developed in approximately one in three patients and severe cytokine-release syndrome developed in one in five patients. (Funded by Novartis and others; ClinicalTrials.gov number, NCT02030834 .).