A single-arm, single-center, open-label clinical study comprising three cohorts, evaluating the safety, preliminary efficacy, and pharmacokinetic/ pharmacodynamic (PK/PD) characteristics of autologous tumor-reactive T cells (GK02) derived from malignant ascites caused by advanced solid tumors. The trial initially plans to enroll 9 subjects with malignant ascites caused by advanced solid tumors.
To evaluate the safety and preliminary efficacy of an investigational cell therapy, Autologous Tumor-reactive T Cells (GK02) derived from malignant ascites caused by advanced solid tumors. Following intraperitoneal infusion of GK02, the safety and tolerability of the subjects will be observed, the preliminary effectiveness of the investigational product GK02 in treating malignant ascites will be evaluated, and the pharmacokinetic/pharmacodynamic (PK/PD) characteristics post-administration will be exploratively assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Autologous tumor-reactive T cells
Beijing GoBroad Hospital
Beijing, China
RECRUITINGIncidence of AEs
Incidence and severity of AEs, including but not limited to vital signs, physical examination, laboratory tests. All AEs will be classified as Grades 1 through 5 as defined by NCI CTCAE v5.0.
Time frame: 12 months
Incidence of DLTs
Number of DLTs (dose limiting toxicities) during the first 28 days after the administrations of GK02 in each cohort.
Time frame: 28 days
Changes in the volume of malignant ascites
Change in malignant ascites volume at 28D(day)、2、3、4、5、6、9、12M(month) after GK02 treatment compared to baseline (prior to GK02 infusion).
Time frame: 12 months
PuFS
From the first infusion of GK02 to the first paracentesis for ascites drainage or death from any cause.
Time frame: 12 months
OS
OS will be assessed from the first GK02 infusion to death from any cause.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.