A Phase 1 interventional study of Granulocyte infusion in Solid Tumor, Adult and Advanced Cancer, sponsored by Wuxi People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-05.
Sponsored by Wuxi People's Hospital · Phase 1, Interventional, and Treatment
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.
4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.
This study's planned enrollment of 18 is below the median of 50 across 3,374 interventional studies indexed under Recurrence.
Browse Recurrence studies →Wuxi People's Hospital is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
1: Uncontrolled or severe cardiovascular disease, diabetes, major heart disease, such as arrhythmia within 30 days, congestive heart failure, or severe coronary artery disease
2: HIV infection, no recent (within 30 days) use of immunosuppressive drugs other than steroids
3: Pregnant and lactating women
4: Previous history of stem cell and organ transplantation
5: Patients who have been using or are using immunosuppressants for a long time
6: Symptomatic brain metastases are not controlled
7: People who are known to be severely allergic to granulocyte infusion (or test positive for anti-neutrophil antibodies)
8: People with coagulation disorders
9: Mental disorders are not under control
10: Patients with severe autoimmune diseases
11: Cases deemed unsuitable for inclusion by the investigator
Experimental: Anticancer mouse characteristic human granulocyte treatment of advanced recurrent tumors. 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.
Biological: Granulocyte infusion
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.
Clinical 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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Wuxi People's Hospital