Safety and Efficiency of γδ T Cell Against Breast Cancer(Her-, er-, and pr-)

Breast Cancer Clinical Trial

Official title:

γδ T Cell Immunotherapy for Treatment of Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418481
• Other study ID #: Gd T cell
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 13, 2015
• Last updated: July 17, 2016
• Start date: April 2015
• Est. completion date: June 2016

Study information

• Verified date: April 2015
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

In this study, effects of γδT cells on human breast cancer (her2-, er-,pr-) in combination with tumor reducing surgery, for example cryosurgery going to be investigated.

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 and DC-CIK, they will be infused to the patients as immunotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age:18-75

2. Karnofsky performance status >50

3. Diagnosis with breast tumors based on histology or the current accepted radiological measures.

4. Classification tumor,nodes,metastasis-classification(TNM) stage: ?,?,?

5. Will receive cryosurgery, gd Tcells/ DC-CIK.

6. Life expectancy: Greater than 3 months

7. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other kinds of cancer

2. History of coagulation disorders or anemia

3. Patients with heart disease and diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• DC-CIK
DC-CIK cells will be used against tumor cells.
• ?d T Cell
?d T cells will be used against breast tumor.
• Combination
?d T/DC-CIK cells will be used against breast tumor.

Locations

Country	Name	City	State
China	Biological treatment center in Fuda cancer hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Jinan University Guangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced size of the tumors		Up to one year	Yes