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

NCT02662348 | Unknown Phase 1 DMC

• 1 other identifier: 2013-SR-116.F1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Safety as measured by local and systemic toxicities

  Up to 1 year

Secondary Outcomes (5)

• Changes in cytokine profiles and tumor markers in serum before and after treatment

  Baseline to up to 12 months

• Changes in phenotyping induced by immunotherapy in peripheral blood mononuclear cells (PBMC)

  Baseline to up to 12 months

• 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.

  Up to 12 months

• Overall survival

  Up to 12 months

• Progression free survival

  From the beginning of immunotherapy to progression or death, assessed up to 12 months

Study Arms (2)

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.

Drug: Recombinant Human Interleukin-2

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.

Drug: HER2Bi-Armed T Cells

Interventions

Recombinant Human Interleukin-2 DRUG

Given SC

Also known as: Proleukin, Recombinant Human IL-2

Interleukin-2 Transfusion

HER2Bi-Armed T Cells DRUG

Given IV

Also known as: HER2Bi-Armed ATCs

T Cells Transfusion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yi Miao: lead
• Nanjing Abingen Biotech Co. Ltd: collaborator

Study Sites (1)

Unknown Facility

Nanjing, Jiangsu, China

Location

Related Publications (26)

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MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Gallbladder Neoplasms; Intestinal Neoplasms

Interventions

aldesleukin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Biliary Tract Neoplasms; Biliary Tract Diseases; Gallbladder Diseases; Intestinal Diseases

Study Officials

• Yi Miao, PH.D

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Pancreas Research Centre; Director of Institute of Tumor Biology, Jiangsu Province Academy of Clinical Medicine

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 25, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 25, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)