Delving into the Latest Updates on Shanghai Keqi Pharmaceutical Technology Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Shanghai Ultra-T Immune Therapeutics is a wholly-owned subsidiary of Novatim Immune Therapeutics (Zhejiang) Co., Ltd. It was established on November 11, 2018, and is located in Shanghai, China. The company is a biopharmaceutical technology enterprise specializing in the research and clinical application of innovative drugs in the field of tumor immunotherapy. Ultra-T Immune Therapeutics primarily focuses on the research and clinical application of CAR-T cell immunotherapy. With a deep involvement in precision immunotherapy since 2013, the company has established a comprehensive research and production platform covering antibody screening to CAR-T preparation. The company places a significant emphasis on developing highly original therapeutic products. Currently, Ultra-T Immune Therapeutics has obtained multiple patents, including inventions such as a TM4SF1-specific chimeric antigen receptor and its application, a monomeric antibody against BCMA and its application, and a chimeric antigen receptor targeting EpCAM and its application.

Tags

Neoplasms

Fusion protein

Bispecific antibody

Autologous CAR-T

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	3

Top 5 Drug Type	Count

Bispecific antibody	1
Autologous CAR-T	1
Fusion protein	1

Top 5 Target	Count

TM4SF1(transmembrane 4 L six family member 1)	1
IL-2 x PD-1	1
CD19(B-lymphocyte antigen CD19)	1

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.

Start Date31 Oct 2023

Sponsor / Collaborator

Shanghai Keqi Pharmaceutical Technology Co., Ltd.

NCT05673434 / Not yet recruitingNot ApplicableIIT

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.

Start Date30 Jan 2023

Sponsor / Collaborator

Shanghai Changhai Hospital

[+1]

NCT04714593 / Unknown statusPhase 1/2IIT

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.

Start Date15 Jan 2021

Sponsor / Collaborator

Shanxi Province Cancer Hospital

[+1]

100 Clinical Results associated with Shanghai Keqi Pharmaceutical Technology Co., Ltd.

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0 Patents (Medical) associated with Shanghai Keqi Pharmaceutical Technology Co., Ltd.

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100 Deals associated with Shanghai Keqi Pharmaceutical Technology Co., Ltd.

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100 Translational Medicine associated with Shanghai Keqi Pharmaceutical Technology Co., Ltd.

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Pipeline

Pipeline Snapshot as of 23 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Discovery

2

1

IND Application

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