An Open-label, Single-arm, Phase I Clinical Study of GK01 Cell Injection in the Treatment of Patients with Advanced Malignant Solid Tumors
Understanding and voluntarily signing the Informed Consent Form (ICF) prior to any study-related assessments/procedures;
Aged 18 to 70 years old (inclusive) at the time of signing the ICF;
Patients with histologically or cytologically confirmed advanced solid tumors (including but not limited to advanced gastric cancer, non-small cell lung cancer, etc.), who have progressed upon the standard of care (SoC), do not tolerate the SoC, or have no SoC;
At least one resectable tumor lesion that has not been treated with radiation therapy or other topical therapy, and tissue blocks with the total sum of diameter of resected lesions being 1.5-4 cm or weighing ≥ 1.0 g (sourced from a single lesion or multiple lesions) are available for preparation of autologous tumor-infiltrating lymphocytes;
History of serious allergy, or hypersensitivity to any ingredients of the drug to be used in this study, including but not limited to lymphodepleting agents (nab-paclitaxel, cyclophosphamide, fludarabine), contrast agents for imaging examination, contrast media, and GK01 excipients (e.g., dimethyl sulfoxide, etc.);
Use of any investigational drug or systemic anti-tumor therapy (except lymphodepleting conditioning regimen) within 28 days (or 5 half-lives of the drug, whichever is more appropriate at the discretion of the investigator) prior to reinfusion;
Participation in any clinical trial of biological therapy (except for cell therapy that has been fully metabolized) within 28 days prior to the signing of ICF;
Use of extensive radiotherapy within 28 days prior to the signing of ICF, with the exception of topical radiotherapy to non-target lesion(s) that has been administered within 14 days prior to the signing of ICF or is expected to be administered during the study for symptom relief;
Single group
GK01 injection
DrugAutologous tumor-reactive T cells injection
Maximum tolerated dose (MTD) and dose-limiting toxicity (DLT)
The highest dose which the patients can tolerate, and the occurence of DLT events.
Safety and Tolerability
Incidence, severity, and causality of adverse events (AEs) and serious adverse events (SAEs).
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
Progression-free Survival (PFS)
Time from GK01 treatment to disease progression or death
Exploratory Study Endpoints
Relationship between target T cell receptor (TCR) copy number/lymphocyte subsets/cytokines (IFN-γ, TFGb, TNF-α, etc.) and preliminary efficacy.
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Beijing Geekgene Technology Co., LTD
Lead sponsor
Peking University Cancer Hospital & Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
