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

Yi Miao

Status and phase: Unknown; Phase 1

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

Treatments: Drug: Recombinant Human Interleukin-2; Drug: HER2Bi-Armed T Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02662348

2013-SR-116.F1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Interleukin-2 Transfusion

Experimental group

Description:

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

Treatment:

Drug: Recombinant Human Interleukin-2

T Cells Transfusion

Experimental group

Description:

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

Treatment:

Drug: HER2Bi-Armed T Cells