医学
内科学
胃肠病学
中止
造血干细胞移植
移植
耐火材料(行星科学)
不利影响
移植物抗宿主病
外科
天体生物学
物理
作者
Jing Pan,Liping Zhao,Yibing Zhang,Samuel Seery,Yue Tan,Biping Deng,Lingling Shan,Zhuojun Ling,Fan Wu,Zelin Wang,Quangang Wang,Xinjian Yu,Qinlong Zheng,Xiuwen Xu,Ying Yuan,Zhenglong Tian,Yanlei Zhang,Shuixiu Peng,Alex Hongsheng Chang,Xiaoxue Feng
出处
期刊:Blood
[Elsevier BV]
日期:2025-07-25
卷期号:146 (23): 2745-2757
被引量:6
标识
DOI:10.1182/blood.2025029299
摘要
ABSTRACT: This phase 2 trial assessed CD7 chimeric antigen receptor (CAR) T cells derived from previous transplant or newly HLA-matched donors for relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL). Early termination from departmental closure yielded 55 treated patients out of 70 planned. Within 3 months, 89% of treated patients achieved best overall response of partial remission or better. A total of 19 received stem cell transplantation at a median of 1.3 (range, 1.0-10.6) months. After a 26.3-month median follow-up, median event-free survival was 5.0 months (95% confidence interval [4.1-8.4]), with median 8.5-month overall survival (95% confidence interval [6.1-15.6]). No deaths occurred within 30 days; adverse events included cytokine release syndrome in 87% at grades 1 to 2 and 11% at grade 3 and neurotoxicity in 9% at grade 1. In addition, graft-versus-host disease was in 38% at grades 1 to 2 and 2% at grade 3. Grades 1 and 2 infections occurred in 29%. Cytopenias occurred in 4% at grade 2 and 96% at grades 3 and 4. After 30 days, grades 3 to 5 adverse events included cytopenias (grade 3 in 24%; grade 4 in 67%), infections (grade 3 in 9%; grade 4 in 5%; grade 5 in 9%), graft-versus-host disease (grade 3 in 4%; grade 5 in 4%), thrombotic microangiopathy (grade 5 in 4%), and hepatic failure (grade 5 in 2%). Furthermore, 11 encountered nonrelapse mortality after 30 days, representing 20% of treated patients and 35% of responders without consolidatory transplantation. Although effective at inducing remission, death in remission beyond 30 days is a concern. This trial was registered at www.clinicaltrials.gov as #NCT04689659.
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