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在滤泡性淋巴瘤复发/难治时采用 CD19 嵌合抗原受体 T 细胞进行床边治疗。

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

机构信息

Division of Hematology and Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel Hashomer, Israel.

Sackler School of Medicine, Tel Aviv University, Tel-Aviv, Israel.

出版信息

Leuk Lymphoma. 2023 Dec;64(12):1956-1963. doi: 10.1080/10428194.2023.2246611. Epub 2023 Aug 11.

Abstract

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.

摘要

复发/难治性滤泡性淋巴瘤(R/R-FL)患者通常需要接受多线治疗。我们在一家中心进行了一项自体即时 CAR-T 细胞治疗 R/R-FL 患者的 1b/2 期单中心临床试验,这些患者接受了≥2 线治疗。所有入组的 26 例患者均在白细胞分离后中位数 11 天接受了 CAR-T 细胞输注。77%的患者在 POD24 时达到缓解。入组时,85%的患者疾病分期为 III-IV 期,77%的患者 FLIPI 评分高危,77%的患者疾病进展。分别有 12%和 16%的患者发生 3-4 级细胞因子释放和免疫效应细胞相关神经毒性综合征。1 个月时的总缓解率为 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,即时 CAR-T 细胞在 11 天内制备,在高风险 R/R-FL 患者中诱导了高缓解率,且安全性可接受。

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