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MechanismTM4SF1 inhibitors |
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Inactive Indication- |
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First Approval Ctry. / Loc.- |
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Inactive Indication- |
Drug Highest PhaseDiscovery |
First Approval Ctry. / Loc.- |
First Approval Date- |
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Mechanism- |
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Inactive Indication- |
Drug Highest PhaseDiscovery |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价 KQ-2003 CAR-T 细胞在复发/难治性多发性骨髓瘤患者的安全性、耐受性、初步有效性和药代动力学特征的I/IIa 期临床研究
[Translation] A Phase I/IIa clinical study to evaluate the safety, tolerability, preliminary efficacy and pharmacokinetic characteristics of KQ-2003 CAR-T cells in patients with relapsed/refractory multiple myeloma
I期研究(剂量递增研究):
主要目的: (1)评价KQ-2003 CAR-T细胞在R/R MM患者的安全性、耐受性,并确定最大耐受剂量(MTD)、剂量限制性毒性(DLT)和II期推荐剂量(RP2D); (2)考察KQ-2003 CAR-T细胞在R/R MM患者体内的药代动力学(PK)/药效动力学(PD)特征及免疫原性。
次要目的: 评价KQ-2003 CAR-T细胞在R/R MM患者的初步有效性。
IIa期研究(队列扩展研究): 主要目的: 评价KQ-2003 CAR-T细胞RP2D在R/R MM患者的安全性、耐受性和初步有效性;
次要目的: 考察KQ-2003 CAR-T细胞在R/R MM患者体内的PK/PD特征及免疫原性。
[Translation] Phase I study (dose escalation study):
Primary objectives: (1) To evaluate the safety and tolerability of KQ-2003 CAR-T cells in R/R MM patients, and determine the maximum tolerated dose (MTD), dose-limiting toxicity (DLT) and phase II recommended dose (RP2D); (2) To investigate the pharmacokinetic (PK)/pharmacodynamic (PD) characteristics and immunogenicity of KQ-2003 CAR-T cells in R/R MM patients.
Secondary objectives: To evaluate the preliminary efficacy of KQ-2003 CAR-T cells in R/R MM patients.
Phase IIa study (cohort expansion study):
Primary objectives: To evaluate the safety, tolerability and preliminary efficacy of KQ-2003 CAR-T cells RP2D in R/R MM patients;
Secondary objectives: To investigate the PK/PD characteristics and immunogenicity of KQ-2003 CAR-T cells in R/R MM patients.
A Clinical Study on the Safety and Efficacy of CAR-T Therapy for the TM4SF1-positive Tumors of Digestive System
Transmembrane 4 L Six Family Member 1 (TM4SF1) is highly expressed in many tumors of digestive system .
The Chimeric Antigen Receptor T-cells (CAR-T) that target TM4SF1 has been generated in our good manufacturing practices (GMP) facility and the anti-tumor effects have been demonstrated in multiple in vitro and in vivo studies.
Clinical studies are proposed here to evaluate the anti-tumor activity of these cell therapy products for treatment of patients with TM4SF1 positive tumors of digestive system. In this study, the safety, tolerance, and preliminary efficacy of CART-TM4SF1 cells will be examined in patients with refractory/recurrent advanced pancreatic cancer, colorectal cancer, gastric cancer or liver cancer.
Clinical and immunological responses will be evaluated about 30 days and last up to 2 years after CAR-T cell infusion.
A Clinical Study to Evaluate the Safety and Effectiveness of CD19- BCMA CAR - T Cells Immunotherapy in Patients With Relapsed or Refractory Acute B Lymphocytic Leukemia
Evaluation the safety,tolerability, preliminary efficacy,and PK/PD of CD19-CD22 CAR-T cells for the treatment of acute B lymphocytic leukemia.
100 Clinical Results associated with Shanghai Keqi Pharmaceutical Technology Co., Ltd.
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100 Translational Medicine associated with Shanghai Keqi Pharmaceutical Technology Co., Ltd.