Combinational therapy of CAR T-cell and HDT/ASCT demonstrates impressive clinical efficacy and improved CAR T-cell behavior in relapsed/refractory large B-cell lymphoma

医学 细胞因子释放综合征 内科学 肿瘤科 淋巴瘤 自体干细胞移植 移植 嵌合抗原受体 胃肠病学 免疫疗法 癌症
作者
Wei Liu,Wei Liu,Hesong Zou,L.P. Chen,Wenyang Huang,Rui Lv,Yan Xu,Huimin Liu,Yin Shi,Kefei Wang,Li Wang,Wenjie Xiong,Shuhui Deng,Shuhua Yi,Weiwei Sui,Guangxin Peng,Yueshen Ma,Li Wang,Lulu Lv,Jianxiang Wang,Jun Wei,Lugui Qiu,Wenting Zheng,Dehui Zou
出处
期刊:Journal for ImmunoTherapy of Cancer [BMJ]
卷期号:12 (4): e008857-e008857 被引量:3
标识
DOI:10.1136/jitc-2024-008857
摘要

Background Approximately two-thirds of patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) do not respond to or relapse after anti-CD19 chimeric antigen receptor T (CAR T)-cell therapy, leading to poor outcomes. Previous studies have suggested that intensified lymphodepletion and hematological stem cell infusion can promote adoptively transferred T-cell expansion, enhancing antitumor effects. Therefore, we conducted a phase I/II clinical trial in which CNCT19 (an anti-CD19 CAR T-cell) was administered after myeloablative high-dose chemotherapy and autologous stem cell transplantation (HDT/ASCT) in patients with R/R LBCL. Methods Transplant-eligible patients with LBCL who were refractory to first-line immunochemotherapy or experiencing R/R status after salvage chemotherapy were enrolled. The study aimed to evaluate the safety and efficacy of this combinational therapy. Additionally, frozen peripheral blood mononuclear cell samples from this trial and CNCT19 monotherapy studies for R/R LBCL were used to evaluate the impact of the combination therapy on the in vivo behavior of CNCT19 cells. Results A total of 25 patients with R/R LBCL were enrolled in this study. The overall response and complete response rates were 92.0% and 72.0%, respectively. The 2-year progression-free survival rate was 62.3%, and the overall survival was 68.5% after a median follow-up of 27.0 months. No unexpected toxicities were observed. All cases of cytokine release syndrome were of low grade. Two cases (8%) experienced grade 3 or higher CAR T-cell-related encephalopathy syndrome. The comparison of CNCT19 in vivo behavior showed that patients in the combinational therapy group exhibited enhanced in vivo expansion of CNCT19 cells and reduced long-term exhaustion formation, as opposed to those receiving CNCT19 monotherapy. Conclusions The combinational therapy of HDT/ASCT and CNCT19 demonstrates impressive efficacy, improved CNCT19 behavior, and a favorable safety profile. Trial registration numbers ChiCTR1900025419 and NCT04690192 .
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