|
|
|
|
|
|
Drug Highest PhasePhase 1/2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
Mechanism- |
Active Org.- |
|
Active Indication- |
|
Drug Highest PhaseDiscontinued |
First Approval Ctry. / Loc.- |
First Approval Date- |
Target- |
Mechanism- |
Active Org.- |
|
Active Indication- |
|
Drug Highest PhaseDiscontinued |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Not yet recruitingPhase 1 自分泌 PD1 抗体靶向间皮素嵌合抗原受体 T 细胞注射液在间皮素阳性晚期恶性实体瘤受试者中的I/II 期临床研究
[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).
100 Clinical Results associated with Shanghai Cell Therapy Group Pharmaceutical Technology Co., Ltd
0 Patents (Medical) associated with Shanghai Cell Therapy Group Pharmaceutical Technology Co., Ltd
100 Deals associated with Shanghai Cell Therapy Group Pharmaceutical Technology Co., Ltd
100 Translational Medicine associated with Shanghai Cell Therapy Group Pharmaceutical Technology Co., Ltd