[Translation] A single-arm, open-label, Phase I clinical trial evaluating the safety and efficacy of TX103 CAR-T cells in subjects with TX103-positive advanced solid tumors
Ia期:剂量递增阶段
主要目的:1) 评价TX103 CAR-T细胞静脉回输或腹腔回输治疗的安全性和耐受性;2) 根据剂量限制性毒性(DLT)和/或最佳生物剂量,确定TX103 CAR-T细胞静脉回输和腹腔回输的最大耐受剂量(MTD)和/或2期推荐剂量(RP2D)
次要目的:1) 评估TX103 CAR-T 细胞静脉回输或腹腔回输治疗的有效性;2) 评价TX103 CAR-T 不同给药途径、给药剂量的临床药理学特征。
Ib期:扩展阶段
主要目的:探索可能获益的受试人群,初步评价TX103 CAR-T 细胞静脉回输或腹腔回输治疗的抗肿瘤活性。
次要目的:1) 评价TX103 CAR-T 细胞静脉回输或腹腔回输治疗的安全性;2) 评价TX103CAR-T 不同给药途径、给药剂量的临床药理学特征。
[Translation] Phase Ia: Dose escalation phase
Main objectives: 1) Evaluate the safety and tolerability of intravenous or intraperitoneal infusion of TX103 CAR-T cells; 2) Determine the maximum tolerated dose (MTD) and/or recommended dose for phase 2 (RP2D) of intravenous or intraperitoneal infusion of TX103 CAR-T cells based on dose-limiting toxicity (DLT) and/or optimal biological dose
Secondary objectives: 1) Evaluate the efficacy of intravenous or intraperitoneal infusion of TX103 CAR-T cells; 2) Evaluate the clinical pharmacological characteristics of different administration routes and dosages of TX103 CAR-T.
Phase Ib: Extension phase
Main objectives: Explore the population of subjects that may benefit and preliminarily evaluate the anti-tumor activity of intravenous or intraperitoneal infusion of TX103 CAR-T cells.
Secondary objectives: 1) To evaluate the safety of intravenous or intraperitoneal reinfusion of TX103 CAR-T cells; 2) To evaluate the clinical pharmacological characteristics of TX103CAR-T at different administration routes and dosages.