This study is an open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.
Ability to understand and sign a written informed consent document.
At the date of signing ICF, 18 ~70 years old, male or female.
Histologically or cytologically confirmed advanced solid tumors, progressed on standard treatment, or intolerant to standard treatment, or without standard treatment; locally recurrent disease must be unsuitable for radical surgical resection or radiotherapy.
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.
Extensive field radiotherapy within 28 days prior to ICF signing, exception of local radiotherapy for symptomatic palliation of non-target lesions.
Major surgery within 28 days prior to signing the ICF, or planned during the study period.
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)
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
Duration of Response (DOR)
Time from first documented evidence of confirmed CR or PR until the first documented evidence of disease progression or death, whichever occurs earlier
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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:
