NCT02980315

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.1 years

First QC Date

November 30, 2016

Last Update Submit

November 30, 2016

Conditions

Nasopharyngeal Neoplasms

Keywords

nasopharyngeal carcinomaEBV related cancers

Outcome Measures

Primary Outcomes (1)

  • all cause mortality

    one year

Study Arms (2)

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

CAR-T cellsOTHER

the patients treat with CAR-T cells

Also known as: adoptive immunotherapy
CAR-T cells

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of nasopharyngeal carcinoma

You may not qualify if:

  • pregnant woman
  • severe autoimmune diseases
  • serious infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SecondNanjingMU

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal NeoplasmsNasopharyngeal Carcinoma

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Pharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 2, 2016

Study Start

November 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 2, 2016

Record last verified: 2016-11

Locations

CN(1)