肿瘤细胞治疗研究
英文原题：Efficacy and safety of the academic anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel for the treatment of relapsed/refractory follicular lymphoma.
Efficacy and safety of the academic anti-CD19 chimeric antigen receptor T-cell product varnimcabtagene autoleucel for the treatment of relapsed/refractory follicular lymphoma.
接受 var-cel 治疗的 R/R FL 患者获得了极佳的疾病控制，CAR T 细胞存活时间延长，毒性可控。
我们报告了使用学术机构开发的抗CD19嵌合抗原受体（CAR）T细胞产品varnimcabtagene autoleucel（var-cel）治疗复发/难治性（R/R）滤泡性淋巴瘤（FL）患者的结局。患者纳入CART19-BE-01临床试验和同情用药项目。27例FL患者接受治疗。55%的患者发生任意级别细胞因子释放综合征（4%为3级）。仅记录到1例（4%）1级神经毒性。治疗后第+100天客观缓解率为100%（完全缓解率93%），3年缓解持续率为78%。3年无进展生存率和总生存率分别为78%和81%。所有患者均发生B细胞缺失，3年B细胞恢复累积发生率为17%。总之，接受var-cel治疗的R/R FL患者疾病控制效果极佳，CAR-T细胞持久性较长且毒性可管理。本试验注册号：NCT03144583。
We report the outcome of patients with relapsed/refractory (R/R) follicular lymphoma (FL) treated with varnimcabtagene autoleucel (var-cel), an academic anti-CD19 chimeric antigen receptor (CAR) T-cell product. Patients were included in the CART19-BE-01 clinical trial and a compassionate use program. Twenty-seven patients with FL were treated. Cytokine release syndrome (any grade) occurred in 55% of patients (4% Grade 3). Only 1 case (4%) of Grade 1 neurotoxicity was documented. The objective response rate was 100% at Day +100 (93% complete response rate), and the 3-year duration of response was 78%. The 3-year progression-free survival and overall survival were 78% and 81%, respectively. All patients developed B-cell aplasia, and the 3-year incidence of B-cell recovery was 17%. In conclusion, patients with R/R FL treated with var-cel obtained excellent disease control, with prolonged CAR T-cell survival and manageable toxicity. This trial was registered as NCT03144583.
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