医学
嵌合抗原受体
细胞因子释放综合征
微小残留病
淋巴母细胞
细胞疗法
鲁索利替尼
肿瘤科
T细胞
内科学
抗原
骨髓
癌症研究
CD8型
细胞毒性T细胞
细胞因子诱导的杀伤细胞
免疫疗法
汽车T细胞治疗
胃肠病学
颗粒酶B
免疫学
干细胞
免疫系统
生物
细胞培养
遗传学
骨髓纤维化
作者
Shiqi Li,Sanbin Wang,Zhongtao Yuan,Lin Liu,Le Luo,Yu Li,Kun Wu,Jia Liu,Chunhui Yang,Zhimin Li,Sanbin Wang,Lianjun Shen,Xun Ye,Jiaping He,Cong Han,Sanbin Wang,Dingsong Zhang,Yancheng Dong,Lihua Fang,Yingnian Chen,Martina Sersch,Wei William Cao,Sanbin Wang
标识
DOI:10.1158/1078-0432.ccr-20-1271
摘要
Abstract Purpose: Although chimeric antigen receptor T-cell (CAR-T) therapy development for B-cell malignancies has made significant progress in the last decade, broadening the success to treating T-cell acute lymphoblastic leukemia (T-ALL) has been limited. We conducted two clinical trials to verify the safety and efficacy of GC027, an “off-the-shelf” allogeneic CAR-T product targeting T-cell antigen, CD7. Here, we report 2 patients as case reports with relapsed/refractory T-ALL who were treated with GC027. Patients and Methods: Both the trials reported here were open-label and single-arm. A single infusion of GC027 was given to each patient after preconditioning therapy. Result: Robust expansion of CAR-T cells along with rapid eradication of CD7+ T lymphoblasts were observed in the peripheral blood, bone marrow, and cerebrospinal fluid. Both patients achieved complete remission with no detectable minimal residual disease. At data cutoff, 30 September 2020, 1 of the 2 patients remains in ongoing remission for over 1 year after CAR T-cell infusion. Grade 3 cytokine release syndrome (CRS) occurred in both patients and was managed by a novel approach with a ruxolitinib-based CRS management. Ruxolitinib showed promising activity in a preclinical study conducted at our center. No graft-versus-host disease was observed. Conclusions: The two case reports demonstrate that a standalone therapy with this novel CD7-targeted “off-the-shelf” allogeneic CAR-T therapy may provide deep and durable responses in select patients with relapsed/refractory T-ALL. GC027 might have a potential to be a promising new approach for treating refractory/relapsed T-ALL. Further studies are warranted.
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