A Single-Center, Open-Label Clinical Study to Evaluate the Safety, Preliminary Efficacy of GK01 Cell Injection in Subjects with Advanced Solid Tumors Refractory or Intolerant to Standard Therapy
Ability to understand and sign a written informed consent document.
At the date of signing ICF, 18 ~75 years old, male or female.
Advanced lung cancer or esophageal squamous cell carcinoma confirmed by cytology or histopathology, failed or intolerant to standard therapy.
At least one measurable lesion that has not been irradiated or received other local therapies.
History of severe allergy, or hypersensitivity to any component of the drugs used in this study, including but not limited to lymphodepleting chemotherapy drugs, contrast agents for radiological examinations, and excipients of GK01 (such as dimethyl sulfoxide).
Any investigational drug or systemic anti-tumor therapy within 28 days prior to the start of lymphodepleting chemotherapy preconditioning, or within 5 half-lives of the previous drug.
Major surgery within 28 days prior to signing the ICF, or planned during the study period.
Toxicities from previous anti-tumor therapies have not recovered to ≤ Grade 1 or baseline level (according to NCI-CTCAE version 5.0) at the time of signing the ICF, with the exception of alopecia and hyperpigmentation.
Single group
GK01 Injection
DrugAutologous tumor-reactive T cells injection
Safety and Tolerability
The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events)
Count of TCR copies
T-cell receptor sequencing (TCR-seq) by obtaining the copy number of the target GK02 T-cell receptors (TCRs) in peripheral blood：Cmax、Tmax、AUC0-t、AUC0-inf、λz、T1/2.
Concentration of Cytokines
IL-1β、IL-2、IL-4、IL-6、IL-8、TGF-b1、IFN-γ and TNF-α
Percentage of Lymphocyte subsets
Total T cells、Th/Ti cells、Ts/Tc cells、NK cells
Circulating tumor DNA
The time between Circulating tumor DNA (ctDNA) positivity and Clinical Progression
Click on the lead sponsor to view all of their trials.
Beijing Geekgene Technology Co., LTD
Lead sponsor
The First Affiliated Hospital of Nanchang University
Collaborator
