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

NCT ID: NCT02662348

Last Updated: 2016-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-11-30

Brief 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.

Detailed Description

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.

Conditions

Esophageal Cancer; Gastric Cancer; Pancreatic Cancer; Liver Cancer; Gallbladder Cancer; Bowel Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interleukin-2 Transfusion

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

Group Type: EXPERIMENTAL

Recombinant Human Interleukin-2

Intervention Type: DRUG

Given SC

T Cells Transfusion

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

Group Type: EXPERIMENTAL

HER2Bi-Armed T Cells

Intervention Type: DRUG

Given IV

Interventions

Recombinant Human Interleukin-2

Given SC

Intervention Type: DRUG

HER2Bi-Armed T Cells

Given IV

Intervention Type: DRUG

Other Intervention Names

Proleukin; Recombinant Human IL-2; HER2Bi-Armed ATCs

Eligibility Criteria

Inclusion Criteria

1. Patient with Her2-positive neoplasms of digestive system: IHC 3+

2. Clinical staging: Phase III or above

3. Ages: < 65

4. Expected survival time: > 1 year

5. Quality of Life: > 60

6. The functions of important organs( heart, liver, lung, kidney and etc.)are normal

7. The volunteers with informed consent

Exclusion Criteria

1. Patient with Her2-negative neoplasms of digestive system

2. Hepatic renal dysfunction

3. Cardiopulmonary insufficiency

4. Mental disorder

5. Allergic condition

6. With other malignant tumor

7. Lactating women

8. Patients with infection or received chemotherapy in the past two weeks

9. Patient with autoimmune disease using immunosuppressive drug

10. Patient with organ transplantation with long term use of immunosupresive drug

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Abingen Biotech Co. Ltd

OTHER

Sponsor Role: collaborator

Yi Miao

OTHER

Sponsor Role: lead

Responsible Party

Yi Miao

Director of the Pancreas Research Centre; Director of Institute of Tumor Biology, Jiangsu Province Academy of Clinical Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yi Miao, PH.D

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

Nanjing, Jiangsu, China

Countries

China

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Other Identifiers

2013-SR-116.F1

Identifier Type: -

Identifier Source: org_study_id