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床旁抗 CD19 CAR-T 细胞疗法治疗复发/难治性滤泡性淋巴瘤

英文原题:Point-of-care anti-CD19 chimeric antigen receptor T-cell therapy for relapsed/refractory follicular lymphoma.

查看英文原题

Point-of-care anti-CD19 chimeric antigen receptor T-cell therapy for relapsed/refractory follicular lymphoma.

PubMed 2023/08/11(内容时间) Leuk Lymphoma Q3 · IF 2.1(JCR 2025)

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中文摘要

复发/难治性滤泡性淋巴瘤(R/R-FL)患者通常需要多线治疗。我们开展了一项自体即时护理 anti-CD19 嵌合抗原受体(CAR)T 细胞的 1b/2 期单中心临床试验,治疗接受过 2 线治疗的 R/R-FL 患者。入组的全部 26 例患者均在白细胞分离术后中位 11 天接受 CAR-T 细胞输注。77% 的患者为 POD24。入组时,85% 的患者疾病分期为 III-IV 期,77% 的患者 FLIPI 评分为高危,77% 的患者为疾病进展。III-IV 级细胞因子释放综合征和免疫效应细胞相关神经毒性综合征分别发生于 12% 和 16% 的患者。1 个月时总缓解率为 88%。中位随访时间为 15.4 个月。1 年总生存率和无进展生存率分别为 100% 和 63%。总之,在 11 天内制备的即时护理 CAR-T 细胞在高危 R/R-FL 患者中诱导了高缓解率,且安全性可接受。

展开英文摘要原文

Patients with relapsed/refractory follicular lymphoma (R/R-FL) often require multiple treatment lines.

We performed a phase 1b/2 single-center clinical trial of autologous point-of-care anti-CD19 chimeric antigen receptor (CAR) T-cells in R/R-FL patients treated patients with 2 treatment lines. All 26 patients enrolled received CAR T-cell infusion at a median of 11 days after leukapheresis.

Seventy-seven percent of patients had POD24. At enrollment, disease stage was III-IV in 85% of the patients, 77% had high-risk FLIPI score, and 77% had progressive disease. Grade III-IV cytokine release and immune effector cell-associated neurotoxicity syndromes occurred in 12% and 16% of the patients, respectively.

Overall response rate at 1-month was 88%. The median follow-up was 15. 4 months. One-year overall and progression-free survival were 100% and 63%, respectively.

In conclusion, point-of-care CAR T-cell, manufactured within 11 days, induced a high response rate with an acceptable safety profile in patients with high-risk R/R-FL.

论文信息

作者
Fried S、Shkury E、Itzhaki O、Sdayoor I、Yerushalmi R、Shem-Tov N、Danylesko I、Jacoby E
单位
Division of Hematology and Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel Hashomer, Israel.Israel
文献类型
II 期临床试验 · I 期临床试验 · 美国 NIH 资助研究
期刊
Leukemia & lymphoma2023 Dec
原文标识
PubMed 37565578 · DOI 10.1080/10428194.2023.2246611