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

November 30, 2016 updated by: The Second Hospital of Nanjing Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

20

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
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • SecondNanjingMU
        • Contact:

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of nasopharyngeal carcinoma

Exclusion Criteria:

  • •pregnant woman

    • severe autoimmune diseases
    • serious infection

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CAR-T cells
the group treat with CAR-T cells
Other: CAR-T cells
the patients treat with CAR-T cells
Other Names:
  • adoptive immunotherapy
NO_INTERVENTION: placebo
the group treat with CAR-T cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause mortality
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

The Second Hospital of Nanjing Medical University

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

November 1, 2016

Primary Completion (ANTICIPATED)

December 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (ESTIMATE)

December 2, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2016

Last Update Submitted That Met QC Criteria

November 30, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-ky-o43

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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