Back to resultsA New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application
Primary Purpose
Nasopharyngeal Neoplasms
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CAR-T cells
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Neoplasms focused on measuring nasopharyngeal carcinoma, EBV related cancers
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of nasopharyngeal carcinoma
Exclusion Criteria:
•pregnant woman
- severe autoimmune diseases
- serious infection
Sites / Locations
- SecondNanjingMURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CAR-T cells
placebo
Arm Description
the group treat with CAR-T cells
the group treat with CAR-T cells
Outcomes
Primary Outcome Measures
all cause mortality
Secondary Outcome Measures
Full Information
NCT ID
NCT02980315
First Posted
November 30, 2016
Last Updated
November 30, 2016
Sponsor
The Second Hospital of Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02980315
Brief Title
A New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application
Official Title
A New Efficient EBV AssociatedTechnologies of T Cells in Treating Malignant Tumors and Clinical Application
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Nanjing Medical University
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Neoplasms
Keywords
nasopharyngeal carcinoma, EBV related cancers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAR-T cells
Arm Type
Experimental
Arm Description
the group treat with CAR-T cells
Arm Title
placebo
Arm Type
No Intervention
Arm Description
the group treat with CAR-T cells
Intervention Type
Other
Intervention Name(s)
CAR-T cells
Other Intervention Name(s)
adoptive immunotherapy
Intervention Description
the patients treat with CAR-T cells
Primary Outcome Measure Information:
Title
all cause mortality
Time Frame
one year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of nasopharyngeal carcinoma
Exclusion Criteria:
•pregnant woman
severe autoimmune diseases
serious infection
Facility Information:
Facility Name
SecondNanjingMU
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen ren jie, doctor
Phone
008618951762675
Ext
13645151481
Email
renjiechenent@aliyun.com
12. IPD Sharing Statement
Learn more about this trial
A New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application
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