抗CD22/CD19 CAR-T细胞疗法（CART2219.1）治疗成人及儿童复发/难治性B-ALL的I/II期试验
A Phase I/II Trial of Anti-CD22/CD19 CAR-T Cell Therapy, CART2219.1, in Adult and Pediatric Relapsed/Refractory B-ALL
复发/难治B细胞急性淋巴细胞白血病（B-ALL）患者接受靶向CD19的CAR-T治疗后，常因抗原丢失或T细胞功能耗竭而复发。该多中心I/II期试验测试了一种新型串联CAR-T（CART2219.1），它同时识别CD22和CD19两个靶点。11例患者（7名儿童、4名成人）在28天内全部达到完全缓解，其中91%为微小残留病灶阴性；中位随访34个月时，中位总生存期和无白血病生存期均未达到，12个月总生存率为82%、无白血病生存率为64%（均未接受巩固移植）。毒性包括细胞因子释放综合征、血液学毒性和噬血细胞性淋巴组织细胞增多症样综合征；1例因CD19抗原逃逸复发。探索性多组学分析提示，CD22抗原密度较高、特定T细胞亚群特征与持久缓解相关。
为什么推荐给您：双靶点串联CAR-T新结构的早期人体试验，全部缓解且无需移植，属新模态阳性早期结果。
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摘要Abstract
Durable remissions after anti-CD19 chimeric antigen receptor T cell (CAR-T) therapy in relapsed/refractory B-lineage acute lymphoblastic leukaemia are limited by antigen escape and T-cell dysfunction. The tandem CAR22-19/LTG2737 construct links human-derived anti-CD22 and anti-CD19 scFvs to CD8 hinge/transmembrane, 4-1BB, and CD3ζ domains. In a multicentre phase I/II trial, all patients (n=11; 7 children, 4 adults) achieved complete remission by Day 28 (91% minimal residual disease-negative). At a 34-month median follow-up, median overall survival (OS) and leukaemia-free survival (LFS) were not reached. The 12-month OS was 82% (95%CI: 45%-95%) and LFS was 64% (95%CI: 30%-85%) without consolidative transplantation. Immune-effector cell-associated toxicities included cytokine release syndrome, haematotoxicity, and haemophagocytic lymphohistiocytosis-like syndrome. De novo CD19 escape caused one relapse. Exploratory multi-omic profiling linked durable response to higher CD22 antigen density on blasts; pre-infusion CD4 CAR-T cells expressing IL7Rα, LEF1, BACH2, and TCF7 but lower FOXP3; post-infusion NK-like effector CAR-T expansion; and central-memory CAR-T pool maintenance.