研究动态
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含苯达莫司汀的桥接疗法对接受 CD19 CAR T 细胞的 R/R LBCL 患者的疗效和安全性。

Efficacy and safety of bendamustine-containing bridging therapy in R/R LBCL patients receiving CD19 CAR T-cells.

发表日期:2024 Jul
作者: Gloria Iacoboni, Mario A Sánchez-Salinas, Kai Rejeski, Ana Á Martín-López, Mi Kwon, Víctor Navarro, Katarzyna A Jalowiec, Rafael Hernani, Juan L Reguera-Ortega, Laura Gallur, Viktoria Blumenberg, María Herrero-García, Claire Roddie, Ana Benzaquén, Javier Delgado-Serrano, Rebeca Bailén, Cecilia Carpio, Paula Amat, Lucia López-Corral, Lourdes Martín-Martín, Mariana Bastos, Marion Subklewe, Maeve O'Reilly, Pere Barba
来源: Experimental Hematology & Oncology

摘要:

大多数接受嵌合抗原受体 (CAR) T 细胞的复发/难治性 (R/R) 大 B 细胞淋巴瘤 (LBCL) 患者需要在白细胞去除术后进行桥接治疗 (BT)。含苯达莫司汀的治疗方案是一种潜在的 BT 选择。我们的目的是评估该药物以 BT 形式给药时是否会对 CAR-T 结果产生负面影响。我们纳入了来自 6 个中心的 R/R LBCL 患者,他们于 2019 年 2 月至 2022 年 9 月在白细胞去除术后接受了全身 BT;仅接受类固醇治疗或在血浆分离术前暴露于苯达莫司汀的患者被排除在外。患者被分为两个 BT 组,分别使用苯达莫司汀和不使用苯达莫司汀。对 axi-cel 和 tisa-cel 进行了单独的安全性和有效性分析。在接受 BT 的 243 名患者中,62 名患者 (26%) 包括苯达莫司汀 (benda)。非 Benda 组的 BT 进展率较高(62% vs. 45%,p = 0.02)。关于 CAR-T 疗效,使用 axi-cel(70% vs. 53%,p = 0.12)和 tisa-cel(44% vs. 36%,p = 0.70)的 Benda 与非 Benda BT 队列的完全缓解相当。 。此外,axi-cel(56% vs. 43% 和 71% vs. 63%)和 tisa-cel(25% vs. 26% 和 52)BT 组之间的 12 个月无进展生存率和总生存率没有显着差异。 % vs. 48%);当考虑 BT 反应时,没有差异。 BT 组之间每个构建体的 CAR T 细胞扩增相似。在安全性方面,BT 方案的 CRS G ≥3(6% vs. 6%,p = 0.79)、ICANS G ≥3(15% vs. 17%,p = 0.68)、严重感染和输注后中性粒细胞减少症具有可比性。对于 CAR T 细胞制造过程中需要疾病控制的患者来说,含有苯达莫司汀的 BT 方案是安全的。© 2024 作者。约翰·威利 (John Wiley) 出版的 HemaSphere
Bridging therapy (BT) after leukapheresis is required in most relapsed/refractory (R/R) large B-cell lymphoma (LBCL) patients receiving chimeric antigen receptor (CAR) T cells. Bendamustine-containing regimens are a potential BT option. We aimed to assess if this agent had a negative impact on CAR-T outcomes when it was administered as BT. We included R/R LBCL patients from six centers who received systemic BT after leukapheresis from February 2019 to September 2022; patients who only received steroids or had pre-apheresis bendamustine exposure were excluded. Patients were divided into two BT groups, with and without bendamustine. Separate safety and efficacy analyses were carried out for axi-cel and tisa-cel. Of 243 patients who received BT, bendamustine (benda) was included in 62 (26%). There was a higher rate of BT progressors in the non-benda group (62% vs. 45%, p = 0.02). Concerning CAR-T efficacy, complete responses were comparable for benda versus non-benda BT cohorts with axi-cel (70% vs. 53%, p = 0.12) and tisa-cel (44% vs. 36%, p = 0.70). Also, 12-month progression-free and overall survival were not significantly different between BT groups with axi-cel (56% vs. 43% and 71% vs. 63%) and tisa-cel (25% vs. 26% and 52% vs. 48%); there were no differences when BT response was considered. CAR T-cell expansion for each construct was similar between BT groups. Regarding safety, CRS G ≥3 (6% vs. 6%, p = 0.79), ICANS G ≥3 (15% vs. 17%, p = 0.68), severe infections, and neutropenia post-infusion were comparable among BT regimens. BT with bendamustine-containing regimens is safe for patients requiring disease control during CAR T-cell manufacturing.© 2024 The Author(s). HemaSphere published by John Wiley & Sons Ltd on behalf of European Hematology Association.