NCT03183206

Safety and Efficiency of γδ T Cell Against Breast Cancer

γδ T Cell Immunotherapy for Treatment of Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Fuda Cancer Hospital, Guangzhou · Academic / Other
• Sex: Female
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this study, effects of γδT cells on human Breast Cancer in combination with tumor reducing surgery, for example, cryosurgery going to be investigated.

Detailed description

Breast tumor will be removed using tumor reducing surgery such as cryosurgery. PBMC of the patient will be separated from peripheral blood. After making them potential cancer killer γδ T Cell, they will be infused to the patients as an immunotherapy treatment NOTE: Originally, our designed proposal was to use autologous PBMCs from cancer patients to ex vivo expand Vγ9Vδ2-T cells, and then perform adoptive transfer therapy. However, PBMCs of majority of cancer patients could not be effectively expanded, including cell number, cell purity and cell function could not meet the requirements of reinfusion. Meanwhile, those patients could not tolerate 100ml of blood drawing for culture every 2 \~ 3 weeks. Therefore, we submitted new clinical study application to the ethical committee of the Fuda Hospital affiliated with Jinan University (Guangzhou, PR. China) by changing the autologous protocol with the allogeneic protocol. After the allogeneic protocol was approved, we adapted allogeneic cells instead of autologous in our subsequentially clinical study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Cryosurgery , IRE surgery ,surgery	surgery will be used in local tumor
BIOLOGICAL	γδ T cells	γδ T cells will be used against
OTHER	γδ T cells/ Surgery	Combination γδ T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer

Timeline

• Start date: 2017-06-15
• Primary completion: 2018-06-15
• Completion: 2019-06-15
• First posted: 2017-06-12
• Last updated: 2020-07-13

Locations

1 site across 1 country: China