Clinical Study of Granulocyte Infusion for Advanced Cancer

Advanced Cancer Clinical Trial

Official title: Clinical Study of Allogeneic Granulocyte Infusion in the Treatment of Patients With Advanced Cancer

Status Recruiting

Clinical Trial Summary

Background & Rationale:

For years, most tumor immunotherapy researches have focused on T cell and natural killer (NK) cell therapies, most of which involve amplification and modification of the patient's immune cells for reinfusion therapy. However, for the treatment of solid tumors, there is currently little breakthrough. Recently, researchers have reported a colony of cancer-resistant mice developed from a single mouse that was immune to multiple lethal cancer cell injections. Further research revealed that such anti-cancer immunity can cause rapid shrinkage or disappearance of the tumors in other cancer-bearing mice. Interestingly, this therapeutic effect is due to the donor granulocytes, instead of T cells or NK cells. Infusion of granulocytes is a classic therapy in treating infection associated with granulocytopenia. Currently, clinical collection of blood components, including isolation of granulocytes, is a mature technique. The infusion of granulocytes is a viable anticancer therapy combining the classic technique and novel anticancer approach. This proposed trial will test whether granulocyte infusions from healthy unrelated donors can be used to treat advanced cancer. In the proposed trial, up to 100 Subjects with advanced cancer can be entered. Each patient will be given a dose of (2.0-5.0)x10^10 granulocytes from a different healthy donor every week over a course of 5 doses. The trial will evaluate the subject's cancer 7, 30, 90 and 180 days after the last infusion.

Clinical Trial Description

Granulocyte anti-cancer therapy refers to a method in which healthy donor granulocytes with high cancer-killing activity are collected and infused into a specific cancer patient by matching, to achieve the therapeutic anticancer effect. In this proposed trial, up to 100 Subjects with advanced cancer can be entered. Potentially hundreds of healthy Donor-participants will be recruited. First, granulocyte donors will be identified via in-vitro assay of Cancer Killing Activity (CKA), which screens healthy Donor-participants for those with anticancer activity of more than 80%. Secondly, after donor-recipient blood matching, (2.0-5.0)x10^10 granulocytes will be collected from each donor, accounting for about 1/10 of the human body. Each patient will be given a dose of (2.0-5.0)x10^10 granulocytes from a different donor per week over a course of 5 doses (with an ideal total infusion of 2X10^11 granulocytes). After each infusion, the patients will be monitored carefully for possible adverse events. If adverse events occur, the infusion can be slowed down or stopped until the adverse events can be managed. The trial will observe the subject's cancer 7, 30, 90 and 180 days after the last infusion. Target lesions, non-target lesions, and new lesions will be evaluated via medical imaging and tumor markers. The responses will be compared against the measurements at baseline. ;

Related Conditions & MeSH terms

• Advanced Cancer
• Neoplasms

• NCT number: NCT04124666
• Study type: Interventional
• Source: Shanghai East Hospital
• Contact: Wenjun Le, Ph.D
• Phone: (+86)-21-38804518
• Email: wenjunle@tongji.edu.cn
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 1, 2019
• Completion date: September 30, 2022