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NCT02980315 Clinical Trial

A New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application

Nasopharyngeal Neoplasms Clinical Trial

Official title:
A New Efficient EBV AssociatedTechnologies of T Cells in Treating Malignant Tumors and Clinical Application

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02980315
Other study ID # 2016-ky-o43
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received November 30, 2016
Last updated November 30, 2016
Start date November 2016
Est. completion date December 2017

Study information
Verified date November 2016
Source The Second Hospital of Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety of the designed LMP1－CAR －T cells and determine whether the CAR-T cells are effective in the treatment of EBV associated malignant tumors.

Description:

Half of the patients will treat with LMP1-CAR-T cells,while the other half will receive a placebo.During the time of the treatment ,we will supervise the side effect of treated group.At last we compare the survival rate and health condition of the two groups.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Clinical diagnosis of nasopharyngeal carcinoma

Exclusion Criteria:

- •pregnant woman

- severe autoimmune diseases

- serious infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• CAR-T cells
the patients treat with CAR-T cells

Locations
Country Name City State
China SecondNanjingMU Nanjing Jiangsu

Sponsors (1)
Lead Sponsor Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary all cause mortality one year No
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