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RECRUITING
NCT06431100

a Single-arm, Single-center, Open Clinical Study

Sponsor: Beijing Geekgene Technology Co., LTD

View on ClinicalTrials.gov

Summary

This trial plans to enroll many patients with advanced solid tumors to complete GK01 cell transfusion, including but not limited to advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, and non-small cell lung cancer. For patients with advanced solid tumors eligible for inclusion, autologous tumor-reactive T cells (experimental drug GK01) were cultured and prepared, and a certain dose of GK01 cells was given according to the cell transfusion plan, and the safety and tolerability of the patients after transfusion were observed. Exploratory evaluation of pharmacokinetic/pharmacodynamic profiles following reinfusion and initial evaluation of efficacy of investigational drug GK01 cells according to RECIST 1.1 criteria.

Official title: Clinical Study on the Safety and Efficacy of GK01 Autologous Tumor-reactive T Cells (TRT) in Patients With Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

10

Start Date

2023-07-19

Completion Date

2026-11-19

Last Updated

2024-05-28

Healthy Volunteers

No

Interventions

BIOLOGICAL

TCR T-cells

The strengthened T cells are re-infused into the patient to achieve the killing effect

Locations (1)

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China