Safety and Efficiency of γδ T Cell Against Breast Cancer

Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Other: γδ T cells/ Surgery; Procedure: Cryosurgery , IRE surgery ,surgery; Biological: γδ T cells

• Registration Number: NCT03183206
• Lead Sponsor: Fuda Cancer Hospital, Guangzhou

Brief 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.

Study Timeline

• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-08
• Study First Posted: 2017-06-12
• Study Start: 2017-06-15
• Primary Completion: 2018-06-15
• Study Completion: 2019-06-15
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-10
• Last Update Posted: 2020-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Age: 18-75 Karnofsky performance status >50 Diagnosis with Breast Cancer based on histology or the current accepted radiological measures Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ Will receive cryosurgery, IRE, surgery, gd T cells Life expectancy: Greater than 6 months Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria

Patients with other kinds of cancer History of coagulation disorders or anemia Patients with heart disease Insulin dependent diabetes Thyroid disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	γδ T cells/ Surgery	In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery, IRE surgery or open surgery
Group A	Cryosurgery , IRE surgery ,surgery	In this group, the patients will receive under CT Cryosurgery , IRE surgery or open surgery to control the local tumor
Group B	γδ T cells	In this group, the patients will receive multiple high-activity γδ T cell immunotherapies. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets and circulating tumor cell)

Primary Outcome Measures

Name	Time	Method
Relief degree of tumors	3 months
Progress free survival（PFS）	1 year
Overall survival（OS）	3 years

Trial Locations

Locations (1)

Biotherapy center in Fuda cancer hospital; 🇨🇳 Guangzhou, Guangdong, China