T Cell Mediated Adaptive Therapy for Her2-positive Neoplasms of Digestive System
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|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
|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|
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.
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|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
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
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.
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
|Nanjing, Jiangsu, China|
|Principal Investigator:||Yi Miao, PH.D||The First Affiliated Hospital with Nanjing Medical University|