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T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System

NCT02662348 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-01-25

No results posted yet for this study

Summary

This phase I trial is to investigate the safety and the possible side effects of bi-specific antibody armed T-cell therapy when given together with low-dose IL-2 in treating patients with Her2-positive neoplasms of digestive system. Expanded autologues T cells that have been coated with bi-specific antibodies, such as anti-CD3 and anti-human epidermal growth factor receptor 2 (HER2), may stimulate the immune system in different ways and stop tumor cells from growing. Interleukin-2 may stimulate white blood cells to kill tumor cells.

Conditions

Interventions

DRUG

Recombinant Human Interleukin-2

Given SC

DRUG

HER2Bi-Armed T Cells

Given IV

Sponsors & Collaborators

  • Nanjing Abingen Biotech Co. Ltd

    collaborator OTHER

  • Yi Miao

    lead OTHER

Principal Investigators

  • Yi Miao, PH.D · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-11-30
Completion
2017-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02662348 on ClinicalTrials.gov