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

NCT06431100 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2024-05-28

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

TCR T-cells

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

Sponsors & Collaborators

  • Beijing Geekgene Technology Co., LTD

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-19
Primary Completion
2026-07-19
Completion
2026-11-19

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06431100 on ClinicalTrials.gov