Safety and Efficiency of γδ T Cell Against Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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γδ T Cell Immunotherapy for Treatment of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Cryosurgery , IRE surgery ,surgery
* Biological: γδ T cells
* Other: γδ T cells/ Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>In this group, the patients will receive under CT Cryosurgery , IRE surgery or open surgery to control the local tumor | Procedure: Cryosurgery , IRE surgery ,surgery<br>* surgery will be used in local tumor<br>|
| Experimental: Group B<br>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) | Biological: γδ T cells<br>* γδ T cells will be used against<br>|
| Experimental: Group C<br>In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery, IRE surgery or open surgery | Other: γδ T cells/ Surgery<br>* Combination γδ T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief degree of tumors |  | 3 months | 
| Progress free survival（PFS） |  | 1 year | 
| Overall survival（OS） |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immunotherapy, γδ T Cell, Breast Cancer