A Single-Arm, Open-Label Clinical Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Participants with Advanced Lung Cancer
Ability to understand and sign a written informed consent document.
At the date of signing ICF, 18 ~75 years old, male or female.
Histologically or cytologically confirmed recurrent, or metastatic advanced lung cancer, progressed on standard treatment, or intolerant to standard treatment.
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 of AEs (Adverse Events) and SAEs (Serious Adverse Events)
Biomarker
Concentration levels of serum cytokines, tumor markers and other related markers，and ctDNA
Pharmacokinetic
Levels of T-cell Receptor copies
Objective response rate (ORR)
Proportion of subjects achieving complete response (CR) and partial response (PR)
Disease Control Rate (DCR)
Proportion of subjects achieving best response of CR, PR, or SD treated with GK01
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This trial is not recruiting at the moment. You can still explore other options:
