A New EBV Related Technologies of T Cells in Treating Mal... | NCT02980315

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

NCT02980315

Sponsor

The Second Hospital of Nanjing Medical University

Status

Unknown status

Last Update Posted

Dec 2, 2016Estimated

Enrollment

20Estimated

Phase

Phase 1Phase 2

Conditions

Nasopharyngeal Neoplasms

Interventions

CAR-T cells

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Nov 30, 2016

First Submission Date that Met QC Criteria

Nov 30, 2016

First Posted Date

Dec 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2016

Last Update Posted Date

Dec 2, 2016Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CAR-T cells	Experimental	the group treat with CAR-T cells	Other: CAR-T cells
placebo	No Intervention	the group treat with CAR-T cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CAR-T cells	Other	the patients treat with CAR-T cells	CAR-T cells	adoptive immunotherapy

Measure	Description	Time Frame
all cause mortality		one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of nasopharyngeal carcinoma

Exclusion Criteria:

•pregnant woman
- severe autoimmune diseases
- serious infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
SecondNanjingMU	Recruiting	Nanjing	Jiangsu	210000	China

Condition Browse Module

MeSH Terms

ID	Term
D009303	Nasopharyngeal Neoplasms
D000077274	Nasopharyngeal Carcinoma

Ancestor Terms

ID	Term
D010610	Pharyngeal Neoplasms
D010039	Otorhinolaryngologic Neoplasms
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016219	Immunotherapy, Adoptive

Ancestor Terms

ID	Term
D019264	Adoptive Transfer
D007116	Immunization, Passive
D007114	Immunization
D007167	Immunotherapy

Browse Leaves

Not provided

Browse Branches

Not provided