[Translation] Phase I/II clinical study of autocrine PD1 antibody targeting mesothelin chimeric antigen receptor T cell injection in subjects with mesothelin-positive advanced malignant solid tumors
主要目的: Ia期:评估aPD1-MSLN-CAR T细胞用于标准治疗失败间皮素阳性的晚期间皮瘤、宫颈癌等恶性实体瘤受试者的安全性和耐受性,确定RP2D。
Ib期:评估aPD1-MSLN-CAR T细胞用于Ib期-队列1和队列2受试者的安全性。
次要目的:
Ia期:初步评价aPD1-MSLN-CAR T细胞用于治疗间皮素阳性晚期恶性实体瘤受试者的有效性,包括客观缓解率(ORR)、疾病控制率(DCR)、总生存期(OS)、无进展生存期(PFS)、缓解持续时间(DOR)。
Ib期:初步评价aPD1-MSLN-CAR T细胞用于治疗Ib期-队列1和队列2受试者的有效性,包括客观缓解率(ORR)、疾病控制率(DCR)、总生存期(OS)、无进展生存期(PFS)、缓解持续时间(DOR)。
[Translation] Primary objectives: Phase Ia: To evaluate the safety and tolerability of aPD1-MSLN-CAR T cells for subjects with advanced mesothelin-positive mesothelioma, cervical cancer and other malignant solid tumors who have failed standard treatment, and determine RP2D.
Phase Ib: To evaluate the safety of aPD1-MSLN-CAR T cells for subjects in Phase Ib-Cohort 1 and Cohort 2.
Secondary objectives:
Phase Ia: To preliminarily evaluate the effectiveness of aPD1-MSLN-CAR T cells for the treatment of subjects with advanced mesothelin-positive malignant solid tumors, including objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and duration of response (DOR).
Phase Ib: To preliminarily evaluate the effectiveness of aPD1-MSLN-CAR T cells for the treatment of subjects in Phase Ib-Cohort 1 and Cohort 2, including objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and duration of response (DOR).