A Phase 1 interventional study of Recombinant Human Interleukin-2 and HER2Bi-Armed T Cells in Esophageal Cancer, Gastric Cancer and Pancreatic Cancer, sponsored by Yi Miao. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-01-25.
Sponsored by Yi Miao · Phase 1, Interventional, and Treatment
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.
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.
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's planned enrollment of 6 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →This is the only study on the registry with Yi Miao as lead sponsor.
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Exclusion criteria:
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
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 SC
Also known as: Proleukin, Recombinant Human IL-2
Given IV
Also known as: 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
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.
Time frame: Baseline to up to 12 months
Changes in phenotyping induced by immunotherapy in peripheral blood mononuclear cells (PBMC)
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.
Time frame: 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.
Point and exact confidence interval estimates will be calculated for response rate.
Time frame: Up to 12 months
Overall survival
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.
Time frame: Up to 12 months
Progression free survival
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.
Time frame: From the beginning of immunotherapy to progression or death, assessed up to 12 months
Plan to share: Yes — Nov 2017 ( Anticipated)
This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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