CTD402, allogeneic anti-CD7 CAR t-cell, in relapsed or refractory (R/R) t-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) - report of clinical outcomes at the recommended phase 2 dose (RP2D)

作者：Peihua Lu, Yongxian Hu, Xian Zhang, Junfang Yang, Xiaoyu Zhu, Ying Wang, Keshu Zhou, Sanbin Wang, Jiang Cao, Heng Mei, Kai Hu, Yong Yu, Yali Zhou, Eileen McNulty, Ming Gao, Maria Delrosario, Wengang Ge, Yonghao Ni, Jiangtao Ren, Jan Davidson‐Moncada, He Huang · 发表于：Blood · 年份：2025 · DOI：10.1182/blood-2025-1042 · 被引用次数：1 · 研究领域：CAR-T cell therapy research、Acute Lymphoblastic Leukemia research、Lymphoma Diagnosis and Treatment

Abstract Background R/R T-ALL/LBL poses significant therapeutic challenge due to paucity, and limited efficacy, of treatments. CTD402, is a CD7 targeted “off-the-shelf” universal CAR-T product with T cell receptor and human leukocyte antigen class II knockout, and improved resistance to host immune rejection achieved by arming the cells with proprietary ANSWERTM inhibitory ligands. CTD402 is currently being developed for the treatment of T-cell hematologic malignancies and other severe blood disorders with ~100 patients (pts) treated in several Phase I/II trials, conducted across 9 centers in China ( NCT05716113; NCT04620655; NCT05454241; NCT05907603; NCT05923541; NCT05902845; and NCT05895994). Herein we present the data of a cohort of these pts treated at the RP2D. Methods The RP2D of CTD402 is 400 million (M) cells administered on day (D) 0 following standard lymphodepleting chemotherapy (sLD)consisting of fludarabine (30 mg/m²/day) and cyclophosphamide (500 mg/m²/day) from days -5 to -3; this is the starting dosing regimen on the ongoing global clinical study (NCT# 07070219). Results Up to a data cutoff June 30th, 2025, 41 R/R T-ALL/LBL (27 ALL, 13 LBL, 1 MPAL) pts, median age 27 years (range 10-56), were treated at the RP2D. Pts had received a median of 2 prior lines of therapy (range 1-6), 37% were primary induction failure, and 24% had relapsed post allogenic hematopoietic stem cell transplant (allo-HSCT); 56% had high-risk molecular profile including ETP phenotype, RAS...