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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03183206
Other study ID # Gd T cell and Breast Ca
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date June 15, 2017
Est. completion date June 15, 2019

Study information

Verified date July 2020
Source Fuda Cancer Hospital, Guangzhou
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 15, 2019
Est. primary completion date June 15, 2018
Accepts healthy volunteers No
Gender Female
Age group 15 Years to 75 Years
Eligibility 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: ?,?,? 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


Related Conditions & MeSH terms


Intervention

Procedure:
Cryosurgery , IRE surgery ,surgery
surgery will be used in local tumor
Biological:
?d T cells
?d T cells will be used against
Other:
?d T cells/ Surgery
Combination ?d T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer

Locations

Country Name City State
China Biotherapy 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 Relief degree of tumors 3 months
Primary Progress free survival(PFS) 1 year
Primary Overall survival(OS) 3 years
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