Delving into the Latest Updates on KSX-01 with Synapse

Overview

Basic Info

Drug Type

TCR therapy

Synonyms

Target-

Mechanism

Immunologic cytotoxicity, T lymphocyte replacements

Therapeutic Areas

Neoplasms

Active Indication

Relapsed Solid Neoplasm

Inactive Indication-

Originator Organization

Keshihua (Nanjing) Biotechnology Co., Ltd.

Active Organization

Keshihua (Nanjing) Biotechnology Co., Ltd.

Inactive Organization-

Drug Highest PhaseEarly Phase 1

First Approval Date-

Regulation-

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This trial is a single arm, open phase I clinical study to investigate the safety and efficacy of personalized KSX01-TCRT in patients with advanced solid tumors. This experiment is divided into two parts: the dose increasing stage (Part A) and the dose expanding stage (Part B). For those enrolled in the planned expansion phase, the dose should have passed the safety assessment during the dose escalation phase.

Start Date07 Nov 2023

Sponsor / Collaborator-

NCT05811975 / RecruitingEarly Phase 1

IIT Clinical Trial on Tolerance, Safety, and Preliminary Efficacy of KSX01-TCRT Injection in Solid Tumor Subjects

1) Safety and efficacy of TCR-T cells in subjects with refractory/relapsed solid tumors. 2) The activation and proliferation of TCR-T cells in the subject, and the survival time.

Start Date07 Mar 2023

Sponsor / Collaborator

Keshihua (Nanjing) Biotechnology Co., Ltd.

100 Clinical Results associated with KSX-01

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100 Translational Medicine associated with KSX-01

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100 Patents (Medical) associated with KSX-01

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100 Deals associated with KSX-01

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Relapsed Solid Neoplasm	Phase 1	CN	Keshihua (Nanjing) Biotechnology Co., Ltd.	07 Mar 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06150365 (KSX01-TCRT, ESMO2024) Manual	Phase 1	Advanced Malignant Solid Neoplasm	6	5x10^9 (Dose 1) TCR T cells	(wecqpqwvgm) = The most common adverse events were neutropenia (Grade 4, 1/6) and decreased white blood cells (Grade 3, 2/6) due to lymphodepleting chemotherapy. No evidence of cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome was observed. bcjxeefstk (zilodymxpu )	Positive	14 Sep 2024
				1x101^10 (Dose 2) TCR T cells