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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Autologous tumor-reactive T cells injection
Tianjin Cancer Hospital Airport Hospital
Tianjin, China
RECRUITINGSafety and Tolerability
The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events).
Time frame: 2 years
PK
Levels of T-cell Receptor copies
Time frame: 2 years
Recurrence free survival(RFS)
RFS will will be assessed from radical surgery to death of any cause (evaluated according to the RECIST criteria).
Time frame: 2 years
Overall survival (OS )
OS will be assessed from the first GK01 infusion to death from any cause (Assessed based on RECIST criteria)
Time frame: 2 years
Patient Quality of Life
EORTC(European Organisation for Research and Treatment of Cancer) QLG (Quality of Life Group)Core Questionnaire (EORTC QLQ-C30)
Time frame: 2 years
PD marker
Concentration levels of serum cytokines, tumor markers and other related markers.
Time frame: 2 years
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