肿瘤细胞治疗研究
英文原题：Locally manufactured versus commercial CAR T therapy for large B-cell lymphoma: a multicenter propensity scorematched analysis.
Locally manufactured versus commercial CAR T therapy for large B-cell lymphoma: a multicenter propensity scorematched analysis.
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本地生产的CAR-T 细胞疗法可实现快速制备，并显著缩短静脉到静脉时间。然而，其与商业化CAR-T 产品相比的临床疗效仍不明确。这项回顾性研究在三个学术中心比较了接受靶向CD19的自体本地生产CAR-T 产品（基于CD28的共刺激）治疗与接受axicabtagene-ciloleucel（axi-cel）或tisagenlecleucel（tisa-cel）治疗的大B细胞淋巴瘤（LBCL）患者的结局。所有患者既往均接受过至少两线治疗。针对CAR-T 产品的倾向性评分分析校正了年龄、Karnofsky体能状态、乳酸脱氢酶（LDH）水平、原发难治性疾病和转化组织学，以解释治疗组之间的基线差异。在330例患者（132例axi-cel、104例tisa-cel、94例本地生产产品）中，接受本地生产CAR-T 治疗的患者更年轻、体能状态更高，且更常表现为LDH升高和原发难治性疾病。
从单采到CAR-T 输注的中位时间在本地生产CAR-T（11天）中显著短于axi-cel（38天）或tisa-cel（44天）（P<0.001）。在校正分析中，本地生产产品与axi-cel比较时，发现axi-cel有改善无进展生存期的趋势（加权风险比[WHR]=1.54；95%置信区间[95% CI]：1.00-2.37；P=0.051），而接受本地生产产品者与tisa-cel之间无差异（WHR=0.71；95% CI：0.45-1.11；P=0.13）。总生存期在各治疗组间相当：本地生产产品与axi-cel比较（WHR=1.35，95% CI：0.87-2.10；P=0.18)，以及本地生产产品对比 tisa-cel（WHR=0.85，95% CI：0.53-1.34；P=0.48）。本地生产的 CAR-T 的 2 级细胞因子释放综合征发生率较低。这些发现支持本地生产的 CAR-T 作为 LBCL 商业产品的临床可比替代方案，并具有对侵袭性疾病患者快速可及的潜在优势。
Locally manufactured chimeric antigen receptor T-cell (CAR T) therapy enables rapid manufacturing and a substantially shorter vein-to-vein time.
However, its clinical efficacy compared to commercial CAR T products remains unclear. This retrospective study compared outcomes in patients with large B-cell lymphoma (LBCL) treated with a CD19-directed autologous locally manufactured CAR T product (CD28-based co-stimulation) versus axicabtagene-ciloleucel (axi-cel) or tisagenlecleucel (tisa-cel) across three academic centers. All patients had received at least two prior lines of therapy. Propensity score analysis for CAR T product adjusted for age, Karnofsky performance status, lactate dehydrogenase (LDH) level, primary refractory disease, and transformed histology was performed to account for underlying differences in treatment groups.
Among 330 patients (132 axi-cel, 104 tisa-cel, 94 locally manufactured products), those treated with locally manufactured CAR T were younger, had higher performance status, and were more likely to present with elevated LDH and primary refractory disease. The median time from apheresis to CAR T infusion was significantly shorter with locally manufactured CAR T (11 days) than with axi-cel (38 days) or tisa-cel (44 days) (P<0.
001). In adjusted analysis, a trend to improved progression-free survival with axi-cel was found when comparing locally manufactured products versus axi-cel (weighted hazard ratio [WHR]=1. 54; 95% confidence interval [95% CI]: 1. 00-2. 37; P=0. 051) and no difference between those given a locally manufactured product versus tisa-cel (WHR=0. 71; 95% CI: 0. 45-1. 11; P=0. 13).
Overall survival was comparable across treatment groups: locally manufactured product versus axi-cel (WHR=1. 35, 95% CI: 0. 87-2. 10; P=0. 18) and locally manufactured product versus tisa-cel (WHR=0. 85, 95% CI: 0. 53-1. 34; P=0. 48). Rates of grade 2 cytokine release syndrome were lower with locally manufactured CAR T.
These findings support locally manufactured CAR T as a clinically comparable alternative to commercial products for LBCL, with the potential advantage of rapid availability for patients with aggressive disease.
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