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含 polatuzumab vedotin 的方案作为 CAR-T 桥接:来自 CART-SIE 研究的分析

英文原题:Polatuzumab vedotin-containing regimens as bridge to CART: analysis from the CART-SIE study.

查看英文原题

Polatuzumab vedotin-containing regimens as bridge to CART: analysis from the CART-SIE study.

PubMed 2026/07/14(内容时间) Blood Adv Q1 · IF 7.7(JCR 2025)

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中文摘要

高肿瘤负荷对LBCL患者抗CD19 CAR-T 治疗的应答产生负面影响。因此,桥接治疗(BT)对于输注前的疾病控制至关重要。

在此,我们在一项纳入200例LBCL患者的前瞻性、多中心、观察性CART-SIE研究队列中,回顾性比较了维泊妥珠单抗(PV)联合利妥昔单抗(PV-R)±苯达莫司汀(PV-BR)的疗效。商业化CAR-T 产品于2020年7月至2025年1月期间输注。患者接受的BT方案为PV-BR(n = 122)或PV-R(n = 78)。中位随访11.9个月时,整个队列CAR-T 输注后的中位PFS和OS分别为10.1个月和35.1个月。比较PV-BR组与PV-R组,患者在接受CAR-T 治疗资格评估时的特征、对BT的客观缓解率(52.5% vs 49.4%;P = .775)、中位PFS(13.4个月 vs 7.4个月;P = .556)和中位OS(未达到 vs 29.0个月;P = .954)均相似。PV-BR组BT后的血液学毒性高于PV-R组(36.4% vs 18.2%;P = .010;≥3级,16.1% vs 6.5%;P = .048),CAR-T 输注后神经毒性发生率亦更高(31.1% vs 15.4%;P = .019)。两组间细胞因子释放综合征和感染发生率相当。CAR-T 输注时的高肿瘤负荷是PFS和OS的独立危险因素。

我们的研究结果证实了BT的作用,并提示PV方案可在T细胞制备期间有效控制疾病。PV-R与PV-BR的缓解率和生存期相似,PV-R显示出毒性更低的趋势,包括神经毒性降低,支持其作为靶向、耐受性良好的桥接方案的潜力。

展开英文摘要原文

High tumor burden negatively affects responses to anti-CD19 chimeric antigen receptor T-cell (CART) therapy in large B-cell lymphoma (LBCL).

Therefore, bridging therapy (BT) is crucial for disease control before infusion.

Here, we retrospectively compared polatuzumab vedotin (PV) combined with rituximab (PV-R) ± bendamustine (PV-BR) in a cohort of 200 patients with LBCL enrolled in the prospective, multicenter, observational CART-Società Italiana di Ematologia (SIE) study. Commercial CARTs were infused between July 2020 and January 2025. Patients received BT with either PV-BR (n = 122) or PV-R (n = 78). At median follow-up of 11. 9 months, the median progression-free survival (PFS) and overall survival (OS) in the entire cohort were 10. 1 and 35. 1 months after CART, respectively.

When comparing PV-BR- with PV-R-treated groups, patient characteristics at CART eligibility, objective response rates to BT (52. 5% vs 49. 4%; P = . 775), median PFS (13. 4 months vs 7. 4 months; P = . 556), and median OS (not reached vs 29. 0 months; P = . 954) were similar. Hematological toxicities after BT were higher with PV-BR than PV-R (36.

4% vs 18. 2%; P = . 010; grade ≥3, 16. 1% vs 6. 5%; P = . 048), as were rates of neurotoxicity after CART (31. 1% vs 15. 4%; P = . 019). Rates of cytokine release syndrome and infections were comparable between the 2 groups. High tumor burden at CART infusion was independent risk factor for both PFS and OS.

Our findings confirmed the role of BT and suggested that PV regimens may effectively control the disease during T-cell manufacturing. Responses and survival were similar between PV-R and PV-BR, with PV-R showing a trend toward lower toxicity, including reduced neurotoxicity, supporting its potential as a targeted, well-tolerated bridging regimen.

论文信息

作者
Gabrielli G、Casadei B、Chiappella A、Tisi MC、Galli E、Cutini I、Di Rocco A、Donzelli L
单位
Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy.Italy
文献类型
多中心研究 · 观察性研究
期刊
Blood advances2026 Jul 14
原文标识
PubMed 42085605 · DOI 10.1182/bloodadvances.2025018749