Bioheng Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application.

生物恒健制药公司已获得美国食品药品监督管理局 (FDA) 对其研究性新药 (IND) 申请的批准。

CTD402 is a universal CAR-T cell product targeting CD7. Developed from healthy donor cells, it is designed to avoid fratricide, graft-versus-host disease (GvHD), and host-versus-graft rejection (HvG), while improving anti-tumour activity.

CTD402是一种靶向CD7的通用型CAR-T细胞产品。该产品由健康供体细胞开发，旨在避免自相残杀、移植物抗宿主病 (GvHD) 和宿主抗移植物排斥反应 (HvG)，同时提升抗肿瘤活性。

The therapy is manufactured in a way that enables a single batch to treat multiple patients, supporting its potential as an off-the-shelf treatment option.

该疗法的生产工艺使得单一批次可以治疗多位患者，这有助于其成为一种现货供应的治疗选择。

T-ALL and LBL are related blood cancers that develop from immature T-cell lymphoid cells. They are classified based on the extent of bone marrow involvement.

T-ALL和LBL是相关的血液癌症，由未成熟的T细胞淋巴细胞发展而来。它们根据骨髓受累程度进行分类。

While standard treatments can achieve high complete remission (CR) rates, many patients eventually relapse. Relapsed or refractory (R/R) disease remains a significant challenge, with long-term survival rates of less than 20%.

虽然标准治疗可以达到较高的完全缓解（CR）率，但许多患者最终会复发。复发或难治性（R/R）疾病仍然是一个重大挑战，长期生存率低于20%。

The FDA’s clearance for CTD402 marks an important step towards addressing this urgent medical need.

FDA对CTD402的批准标志着解决这一紧迫医疗需求的重要一步。

The approval allows the company to proceed with clinical trials of CTD402, a CD7-targeted universal CAR-T (UCAR-T) cell therapy, for paediatric and adult patients with relapsed or refractory T-cell acute lymphoblastic leukaemia/lymphoma (R/R T-ALL/LBL).

该批准允许该公司继续进行CTD402的临床试验，这是一种针对CD7的通用CAR-T（UCAR-T）细胞疗法，用于治疗复发或难治性T细胞急性淋巴细胞白血病/淋巴瘤（R/R T-ALL/LBL）的儿童和成人患者。

The upcoming trial, a Phase Ib/II study, will follow a single-arm, open-label design with a simplified dose-finding approach.

即将到来的试验是一项Ib/II期研究，将采用单臂、开放标签的设计，并使用简化的剂量探索方法。

This structure aims to optimise dosing and speed up clinical development in the United States.

该结构旨在优化剂量，并加速美国的临床开发进程。

Source: prnewswire.com

来源：prnewswire.com