RecruitingNCT06431100

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

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


Sponsor

Beijing Geekgene Technology Co., LTD

Enrollment

10 participants

Start Date

Jul 19, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized immune cell therapy — using immune cells extracted from your own tumor tissue or fluid — in people with advanced cancers that have stopped responding to standard treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with advanced gastric cancer, esophageal cancer, cervical cancer, triple-negative breast cancer, non-small cell lung cancer, or another solid cancer - Standard treatments have stopped working or you cannot tolerate them - You have enough tumor tissue or fluid available (from a biopsy or chest/abdominal fluid) to prepare the cell therapy - Your general health and organ function meet the study requirements **You may NOT be eligible if...** - You have serious infections or immune system problems - You have significant heart, liver, or kidney disease - You are pregnant or breastfeeding - You have received certain immunotherapy treatments recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTCR 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

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NCT06431100


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