NCT06240767

Clinical Study on the Treatment of Advanced Recurrent Tumors With Anticancer Mouse Characteristic Human Neutrophils

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Wuxi People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Solid Tumor, Adult
• Advanced Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-01
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2024-02-05
• Last updated: 2024-02-05

Locations

1 site across 1 country: China