Trial | NCT02662348  Report issue

Official Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    6
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.
PRIMARY OBJECTIVES:

I. Perform a phase I clinical trial to clearly define the toxicity profile of IV HER2Bi armed T cells in patients with neoplasms of digestive system.

SECONDARY OBJECTIVES:

I. Evaluate phenotype, cytokine profiles and tumor markers, cytotoxicity directed at laboratory Her2 positive cancer cell lines.

II. Evaluate the clinical symptoms and signs, clinical responses, imaging examination of pretherapy and post-treatment, cytokine profiles and tumor markers in serum before and after treatment, time to progression, and overall survival.

OUTLINE: This is a safety study of IV infused HER2Bi-armed activated T cells. Patients receive HER2Bi armed T cells IV weekly for 4 weeks. Patients also receive low-dose Interleukin subcutaneously (SC) daily beginning 3 days before the first HER2Bi armed T cells infusion. Treatment continues in the absence of disease progression or unacceptable toxicity.
Study Started
Feb 29
2016
Primary Completion
Nov 30
2017
Anticipated
Study Completion
Nov 30
2017
Anticipated
Last Update
Jan 25
2016
Estimate

Drug Recombinant Human Interleukin-2

Given SC

  • Other names: Proleukin, Recombinant Human IL-2

Drug HER2Bi-Armed T Cells

Given IV

  • Other names: HER2Bi-Armed ATCs

Interleukin-2 Transfusion Experimental

Patients receive low-dose Recombinant Human Interleukin-2 SC daily beginning 3 days before the first HER2Bi armed T cell infusions infusion.

T Cells Transfusion Experimental

Patients receive HER2Bi-Armed T Cells IV weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Criteria 

Inclusion Criteria:

Patient with Her2-positive neoplasms of digestive system: IHC 3+
Clinical staging: Phase III or above
Ages: < 65
Expected survival time: > 1 year
Quality of Life: > 60
The functions of important organs( heart, liver, lung, kidney and etc.)are normal
The volunteers with informed consent

Exclusion criteria:

Patient with Her2-negative neoplasms of digestive system
Hepatic renal dysfunction
Cardiopulmonary insufficiency
Mental disorder
Allergic condition
With other malignant tumor
Lactating women
Patients with infection or received chemotherapy in the past two weeks
Patient with autoimmune disease using immunosuppressive drug
Patient with organ transplantation with long term use of immunosupresive drug
No Results Posted