Safety and Efficiency of γδ T Cell Against Breast Cancer

July 10, 2020 updated by: Fuda Cancer Hospital, Guangzhou

γδ T Cell Immunotherapy for Treatment of Breast Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510665
        • Biotherapy center in Fuda cancer hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
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
surgery will be used in local tumor
Experimental: 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)
Biological: γδ T cells
γδ T cells will be used against
Experimental: Group C
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
Combination γδ T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuda Cancer Hospital, Guangzhou

Collaborators

Jinan University Guangzhou

Investigators

  • Principal Investigator: Jibing Chen, PhD, Biological treatment center in Fuda cancer hospital Guangzhou, Guangdong, China, 510000

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2017

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

June 15, 2019

Study Registration Dates

First Submitted

June 8, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 12, 2017

Study Record Updates

Last Update Posted (Actual)

July 13, 2020

Last Update Submitted That Met QC Criteria

July 10, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gd T cell and Breast Ca

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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