KSH01 injection

clinical trials ksh

1. . safety and tolerance
2. . objective response rate

1. . To evaluate the safety and tolerance of autologous TCR-T cells in target positive solid tumor patients.
2. . Preliminary evaluation of objective response rate (ORR) of autologous TCR-T cells in target positive solid tumor patients (such as esophageal cancer, gastric cancer, head and neck cancer, bladder cancer, melanoma, sarcoma, etc.)

KSH01-R02-101 Solid Tumors

Investigator Initiated Clinical Trial on the Tolerance, Safety and Preliminary Efficacy of KSH01-TCRT Injection in Solid Tumor Subjects

To evaluate the safety and tolerance of autologous TCR-T cells in target positive solid tumor subjects.

To preliminarily evaluate the objective remission rate of autologous TCR-T cells in the treatment of target positive solid tumor subjects (such as esophageal cancer, gastric cancer, head and neck cancer, bladder cancer, melanoma, sarcoma, etc.).

Preliminary evaluation of anti-tumor efficacy of autologous TCR-T cells in solid tumor subjects

To evaluate the pharmacokinetics of autologous TCR-T cells in solid tumor subjects

To evaluate the cytokine level of autologous TCR-T cells in solid tumor patients during treatment

Evaluation of biomarker characteristics of autologous TCR-T cells in solid tumor subjects

TCRx Therapeutics Co.Ltd

Symptoms and General Pathology

All Conditions

Recurrence

Jie Ma

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.

KSH01-TCRT Solid Tumors

A Single-arm, Prospective Clinical Study of KSH01-TCR-T in the Treatment of Refractory/Recurrent Solid Tumors

Pharmacokinetic Values of blood test values

Biomarker Features values of blood test values

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
KSH01-R02-101 Solid Tumors	NCT05580796	Solid Tumor	KSH01 injection	18 Years - 70 Years	TCRx Therapeutics Co.Ltd
KSH01-TCRT Solid Tumors	NCT05539833	TCR-T Cells Refractory Soli... Relapsed Solid ...	KSH01 injection	18 Years - 70 Years	TCRx Therapeutics Co.Ltd
KSH01-R02-101 Solid Tumors	NCT05580796	Solid Tumor	KSH01 injection	18 Years - 70 Years	TCRx Therapeutics Co.Ltd

Spots Global Cancer Trial Database for ksh01 injection