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

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.

NCT Number	NCT06431100
Lead Sponsor	Beijing Geekgene Technology Co., LTD
Conditions	Gastric Cancer, Esophageal Cancer, Cervical Cancer, Non-Small Cell Lung Cancer NSCLC, Triple Negative Breast Cancer TNBC
Enrollment	10 participants
Start Date	2023-07-19
Primary Completion	2026-07-19 (estimated)
Study Completion	2026-11-19 (estimated)
Updated on ClinicalTrials.gov	2024-05-28