T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02662348 |
Recruitment Status : Unknown
Verified January 2016 by Yi Miao, The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was: Enrolling by invitation
First Posted : January 25, 2016
Last Update Posted : January 25, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Esophageal Cancer Gastric Cancer Pancreatic Cancer Liver Cancer Gallbladder Cancer Bowel Cancer | Drug: Recombinant Human Interleukin-2 Drug: HER2Bi-Armed T Cells | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 6 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System |
Study Start Date : | February 2016 |
Estimated Primary Completion Date : | November 2017 |
Estimated Study Completion Date : | November 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: 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.
|
Drug: Recombinant Human Interleukin-2
Given SC
Other Names:
|
Experimental: 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.
|
Drug: HER2Bi-Armed T Cells
Given IV
Other Name: HER2Bi-Armed ATCs |
- Safety as measured by local and systemic toxicities [ Time Frame: Up to 1 year ]
- Changes in cytokine profiles and tumor markers in serum before and after treatment [ Time Frame: Baseline to up to 12 months ]Increases or decreases in the amount of cytokine produced from the pre-immunotherapy baseline at any time point after immunotherapy will be considered as continuous outcomes.
- Changes in phenotyping induced by immunotherapy in peripheral blood mononuclear cells (PBMC) [ Time Frame: Baseline to up to 12 months ]PBMC from the patients will be obtained before and after immunotherapy to determine if there are any phenotype changes induced by immunotherapy. Paired t-test will be used to compare the difference between baseline and after any time point of armed T cells treatment in T cell subpopulation (FACS), tumor marker (CBA/ELISA) and tumor killing ability of PBMC.
- 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. [ Time Frame: Up to 12 months ]Point and exact confidence interval estimates will be calculated for response rate.
- Overall survival [ Time Frame: Up to 12 months ]Will be estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 6 month, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates will be calculated.
- Progression free survival [ Time Frame: From the beginning of immunotherapy to progression or death, assessed up to 12 months ]Will be estimated with the standard Kaplan-Meier method, from which summary statistics of interest (median, 6 month, 1-year rate, etc.) will be derived. Both point and 95% confidence interval estimates will be calculated.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02662348
China, Jiangsu | |
Nanjing, Jiangsu, China |
Principal Investigator: | Yi Miao, PH.D | The First Affiliated Hospital with Nanjing Medical University |
Responsible Party: | Yi Miao, Director of the Pancreas Research Centre; Director of Institute of Tumor Biology, Jiangsu Province Academy of Clinical Medicine, The First Affiliated Hospital with Nanjing Medical University |
ClinicalTrials.gov Identifier: | NCT02662348 |
Other Study ID Numbers: |
2013-SR-116.F1 |
First Posted: | January 25, 2016 Key Record Dates |
Last Update Posted: | January 25, 2016 |
Last Verified: | January 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Nov 2017 ( Anticipated) |
Neoplasms Gallbladder Neoplasms Digestive System Neoplasms Gastrointestinal Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Biliary Tract Neoplasms Biliary Tract Diseases Gallbladder Diseases Aldesleukin |
Interleukin-2 Antineoplastic Agents Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |