Delving into the Latest Updates on Shanghai Keji Pharmaceutical Co. Ltd. with Synapse

Overview

Basic Info

Introduction

Keji Pharmaceuticals is a biopharmaceutical enterprise operating within both China and the United States, primarily dedicating its efforts to the development of pioneering Chimeric Antigen Receptor T-cell (CAR-T) therapies aimed at combating solid tumors as well as hematological malignancies.

Tags

Neoplasms

Immune System Diseases

Endocrinology and Metabolic Disease

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	2
Immune System Diseases	1
Endocrinology and Metabolic Disease	1
Hemic and Lymphatic Diseases	1

Top 5 Drug Type	Count

Autologous CAR-T	2

Top 5 Target	Count

CD19(B-lymphocyte antigen CD19)	1
CLDN18.2(Claudin 18.2)	1

主要目的：评价CT041用于胰腺癌术后辅助治疗的有效性；次要目的：评价CT041治疗的安全性和耐受性，评价CT041用于胰腺癌术后辅助治疗受试者的其他有效性指标，评价受试者输注CT041的细胞代谢动力学，评价受试者输注CT041的免疫原性探索性目的：探索影响CT041有效性的因素，探索CT041对受试者生活质量的影响

[Translation]

Primary purpose: To evaluate the effectiveness of CT041 in adjuvant therapy for pancreatic cancer after surgery; Secondary purpose: To evaluate the safety and tolerability of CT041 treatment, to evaluate other effectiveness indicators of CT041 in adjuvant therapy for pancreatic cancer after surgery, to evaluate the cellular metabolic kinetics of CT041 infused into subjects, and to evaluate the immunogenicity of CT041 infused into subjects Exploratory purpose: To explore the factors affecting the effectiveness of CT041 and the effect of CT041 on the quality of life of subjects

Start Date03 Aug 2023

Sponsor / Collaborator

Shanghai Keji Pharmaceutical Co. Ltd.

CTR20201940

/ RecruitingPhase 1/2

一项开放、多中心、Ib/II期临床试验，评价CT041自体CAR T细胞注射液在晚期胃/食管胃结合部腺癌和胰腺癌受试者中的有效性、安全性与细胞代谢动力学

[Translation] An open, multicenter, Phase Ib/II clinical trial evaluating the efficacy, safety, and cellular metabolic dynamics of CT041 autologous CAR T cell injection in subjects with advanced gastric/esophagogastric junction adenocarcinoma and pancreatic cancer

Ib期剂量探索阶段的主要目的：评价两组受试者首次输注CT041后4周内的安全性和耐受性确定RP2D; Ib期剂量扩展阶段和II期有效性安全性确认阶段的主要目的：评价总队列1受试者输注CT041后24周内的有效性；评价总队列2受试者输注CT041后12周内的有效性。

[Translation]

The main purpose of the Phase Ib dose exploration phase: to evaluate the safety and tolerability of the two groups of subjects within 4 weeks after the first infusion of CT041 to determine the RP2D; The main purpose of the Phase Ib dose expansion phase and the Phase II efficacy and safety confirmation phase: to evaluate the efficacy of the total cohort 1 subjects within 24 weeks after the infusion of CT041; to evaluate the efficacy of the total cohort 2 subjects within 12 weeks after the infusion of CT041.

Start Date23 Oct 2020

Sponsor / Collaborator

Shanghai Keji Pharmaceutical Co. Ltd.

CTR20191134

/ Active, not recruitingPhase 1/2

一项开放、多中心Ⅰ/Ⅱ期临床研究，评价CT032人源化抗CD19自体CAR T细胞注射液在R/R B-NHL患者中的安全性和有效性

[Translation] An open-label, multicenter Phase I/II clinical study evaluating the safety and efficacy of CT032 humanized anti-CD19 autologous CAR T cell injection in patients with R/R B-NHL

I期主要目的为评价CT032 CAR-CD19 T细胞注射液在复发/难治的非霍奇金B细胞淋巴瘤患者2个月的安全性和耐受性；确定CT032 CAR-CD19 T细胞的治疗的II期临床试验推荐剂量（RP2D）；II期主要目的为评价CT032 CAR-CD19 T细胞治疗R/R B-NHL患者6个月的疗效。

[Translation]

The main purpose of Phase I is to evaluate the safety and tolerability of CT032 CAR-CD19 T cell injection in patients with relapsed/refractory non-Hodgkin's B-cell lymphoma for 2 months; to determine the recommended dose (RP2D) of Phase II clinical trial for CT032 CAR-CD19 T cell treatment; the main purpose of Phase II is to evaluate the efficacy of CT032 CAR-CD19 T cell treatment in patients with R/R B-NHL for 6 months.

Start Date13 Aug 2019

Sponsor / Collaborator

Shanghai Keji Pharmaceutical Co. Ltd.

100 Clinical Results associated with Shanghai Keji Pharmaceutical Co. Ltd.

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0 Patents (Medical) associated with Shanghai Keji Pharmaceutical Co. Ltd.

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100 Deals associated with Shanghai Keji Pharmaceutical Co. Ltd.

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100 Translational Medicine associated with Shanghai Keji Pharmaceutical Co. Ltd.

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Pipeline

Pipeline Snapshot as of 04 Aug 2026

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

Phase 2 Clinical

2

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Satricabtagene autoleucel ( CLDN18.2 )	Advanced Gastric Adenocarcinoma More	Phase 2 Clinical
CT-032 ( CD19 )	B-cell lymphoma refractory More	Phase 2 Clinical