Safety and Efficiency of γδ T Cell Against Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-15

Study Completion Date

2019-06-15

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.

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group A

In this group, the patients will receive under CT Cryosurgery , IRE surgery or open surgery to control the local tumor

Group Type EXPERIMENTAL

Cryosurgery , IRE surgery ,surgery

Intervention Type PROCEDURE

surgery will be used in local tumor

Group B

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)

Group Type EXPERIMENTAL

γδ T cells

Intervention Type BIOLOGICAL

γδ T cells will be used against

Group C

In this group, the patients will receive multiple high-activity γδ T cell immunotherapies and Cryosurgery, IRE surgery or open surgery

Group Type EXPERIMENTAL

γδ T cells/ Surgery

Intervention Type OTHER

Combination γδ T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer

Interventions

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Cryosurgery , IRE surgery ,surgery

surgery will be used in local tumor

Intervention Type PROCEDURE

γδ T cells

γδ T cells will be used against

Intervention Type BIOLOGICAL

γδ T cells/ Surgery

Combination γδ T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer

Intervention Type OTHER

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