Clinical trial NCT02662348: T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System
Official title: T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Liver Cancer
Gallbladder Cancer
Bowel Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Abingen Biotech Co. Ltd
First posted: 2016-01-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety as measured by local and systemic toxicities
timeFrame: Up to 1 year
Secondary outcomes:
measure: Changes in cytokine profiles and tumor markers in serum before and after treatment
timeFrame: Baseline to up to 12 months
measure: Changes in phenotyping induced by immunotherapy in peripheral blood mononuclear cells (PBMC)
timeFrame: Baseline to up to 12 months
measure: Clinical response rate (including clinical symptoms and signs, complete response, partial response, progressive disease, and stable disease, imaging examination of pretherapy and post-treatment) will be measured by follow-up investigation.
timeFrame: Up to 12 months
measure: Overall survival
timeFrame: Up to 12 months
measure: Progression free survival
timeFrame: From the beginning of immunotherapy to progression or death, assessed up to 12 months
Other outcomes:
Locations:
city: Nanjing
country: China
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Yi Miao, PH.D
role: PRINCIPAL_INVESTIGATOR
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