[Translation] A single-arm, open-label phase I clinical study evaluating the safety, tolerability, and preliminary efficacy of QH104A cell injection in patients with recurrent or progressive central nervous system malignancies.
评价QH104A在B7-H3阳性复发或进展的CNS恶性肿瘤患者中的安全性、耐受性和初步疗效;根据剂量限制性毒性(DLT),确定QH104A脑室输注的最大耐受剂量(MTD)和/或2期推荐剂量(RP2D);探索治疗后药代、药效动力学及免疫反应。
[Translation] To evaluate the safety, tolerability, and preliminary efficacy of QH104A in patients with B7-H3-positive recurrent or progressive CNS malignancies; to determine the maximum tolerated dose (MTD) and/or the recommended dose for phase 2 (RP2D) of QH104A intravenous infusion based on dose-limiting toxicities (DLT); and to explore pharmacokinetic, pharmacodynamic, and immune responses after treatment.