It is planned to recruit about 100 pathologically confirmed subjects with advanced solid tumors (non-small cell lung cancer, breast cancer, ovarian cancer, stomach cancer, colorectal cancer, pancreatic cancer, mesothelioma, etc.) that have progressed after standard second-line or above treatment such as surgery, chemoradiotherapy, targeted therapy and PD-1 antibody therapy. A single infusion of human granulocytes with anti-cancer mouse characteristics was performed for 5 consecutive transfusions at a interval of 2±1 day, and the safety and efficacy were clinically observed. After the investigator's judgment and discussion with the sponsor, more cycles of treatment can be received after the informed consent is completed until the criteria for stopping treatment are met.
100 cases of advanced cancer with failed chemotherapy or ineffective standard treatment or relief measures were enrolled and clinically observed. Single infusion dose 2.0-5.0 × 1010 granulocytes were continuously infused 5 times every 2 ± 1 day. According to the patient's condition, ensure that the number of subjects with a single tumor is not less than 20.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
The number of single granulocytes per infusion was 2.0-5.0×10\^10, with an interval of 2±1 day and 5 continuous infusions.
Wuxi People's Hospital
Wuxi, Jiangsu, China
RECRUITINGClinical efficacy evaluation
Target lesions were assessed according to RECIST1.1 criteria. All other lesions, including small lesions (lesions with a maximum diameter of less than 20mm measured by conventional methods or less than 10mm measured by spiral CT scanning, or less than 15mm measured when the CT layer thickness is 5mm) and true unmeasurable lesions are not required to be measured, described as "with" or "without".
Time frame: 6 months after treatment
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