肿瘤细胞治疗研究
英文原题：Academic anti CD19 CAR-T cell therapy for relapsed/refractory B-cell lymphomas in real-world clinical practice: a prospective cohort study.
Academic anti CD19 CAR-T cell therapy for relapsed/refractory B-cell lymphomas in real-world clinical practice: a prospective cohort study.
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抗 CD19 CAR-T 细胞产品在 r/r BCL 患者中显示出良好的疗效和可接受的毒性。在无法获得商业产品的国家，使用此类产品是患者唯一可用的选择。
嵌合抗原受体（CAR）T细胞疗法近年来已成为复发/难治性B细胞淋巴瘤（r/r BCLs）的标准治疗。然而，商业产品的高成本限制了其在真实世界临床实践中的应用。使用所谓的学术型CAR-T 细胞产品可以降低成本，并提高该治疗选择的可及性和可负担性。本临床试验的目的是评估学术型CAR-T 细胞在r/r BCL患者中的疗效和安全性。
2021年6月至2025年12月，这项前瞻性临床试验在白俄罗斯N.N. Alexandrov国家癌症中心（白俄罗斯共和国明斯克）入组了76例r/r BCL患者，ClinicalTrials.gov标识符：NCT07524816。患者年龄为23-68岁（中位年龄47岁）。CAR-T 细胞产品使用编码抗CD19 CAR的慢病毒载体制备。
整个队列的中位随访时间为7.85个月，无事件患者的中位随访时间为20.12个月。总体而言，57.5%的患者达到完全缓解。4年无事件生存期（EFS）率为46.2±6.3%，4年总生存期（OS）率为67±5.9%。在滤泡性淋巴瘤（FL）患者中，83.3%达到完全缓解。4年EFS率为81.7±9.6%。安全性特征可接受：43.4%的患者发生细胞因子释放综合征（CRS）（3级占2.6%）。未报告4级CRS病例，26.3%的患者出现神经毒性（ICANS）（3级占5.3%，2例患者发生4级ICANS，占2.6%）。
From June 2021 to December 2025, this prospective clinical trial enrolled 76 r/r BCL patients treated at the N.N. Alexandrov National Cancer Centre of Belarus (Minsk, Republic of Belarus), ClinicalTrials.gov Identifier: NCT07524816. The patients were 23-68 years of age (median 47 years). The CAR-T cell product was manufactured using lentiviral vector encoding anti-CD19 CAR.
The median follow-up was 7.85 months for the entire cohort and 20.12 months for patients without events. Generally, complete response was achieved in 57.5% of patients. The 4-year event-free survival (EFS) rate was 46.2 6.3%, and the 4-year overall survival (OS) rate was 67 5.9%. Among patients with follicular lymphoma (FL), complete response was achieved in 83.3% patients. The 4-year EFS was 81.7 9.6%. The safety profile was acceptable: cytokine release syndrome (CRS) was detected in 43.4% of patients ( grade 3 in 2.6%). No cases of grade 4 CRS were reported, and neurotoxicity (ICANS) was identified in 26.3% of patients ( grade 3 in 5.3%, grade 4 ICANS occurred in two patients - 2.6%).
The anti-CD19 CAR T-cell product demonstrates good efficacy and acceptable toxicity in patients with r/r BCL. The use of such a product is the only available option for patients in countries where commercial products are not accessible. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/study/NCT07524816, identifier NCT07524816.
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