Autologous Immune Enhancement Therapy (AIET) for Cancer Patients

Study Overview
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Brief Summary
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This is a retrospective study that included 60 cancer patients who underwent autologous NK cell and CD8 T cell therapy between January 2016 and December 2021

Detailed Description
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The dysfunction and reduced proliferation of peripheral immune cells including CD8 T and NK cells have been observed in both aging and cancer patients, thereby challenging the immune cell therapy in these subjects. Therefore, we evaluated the growth of these lymphocytes in elderly patients with several types of cancer and the correlation of peripheral blood (PB) indexes to the expansions. This is a retrospective study that included 60 cancer patients who underwent autologous NK cell and CD8 T cell therapy between January 2016 and December 2021. By optimizing the antiviral and tumor surveillance ability of both NK cells and CTLs through serial steps from isolation and expansion, followed by re-infusion of these activated cells back to the patient body, AIET has become a promising, cutting-edge method in detecting and eliminating cancer cells. The study aimed to evaluate the safety and effectiveness of 60 cancer patientsreceiving AIET.

Official Title
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Evaluating Safety and Quality of Life of Cancer Patients Treated by Autologous Immune Enhancement Therapy (AIET) in Vinmec International Hospitals

Conditions
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Patients With Cancer

Intervention / Treatment
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* Combination Product: Autologous immune enhancement therapy (AIET) for cancer patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 - 75 Patients have been diagnosed with cancer. Patients signed the written informed consent form. Exclusion Criteria: Severe health conditions such as serious infection, autoimmune diseases, or using any anti-rejection drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: autologous immune enhancement therapy (AIET) for treating cancer<br>A total of 60 cancer patients received one to seven sittings of natural killer (NK) cells and cytotoxic T lymphocytes (CTLs) infusions. | Combination Product: Autologous immune enhancement therapy (AIET) for cancer patients<br>* Autologous NK cell and CD8 T cell therapy for cancer patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse events and serious adverse events (AEs or SAEs) | the number of AEs or SAEs during and after Autologous Immune Enhancement Therapy (AIET) | up to the 36-month period following treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in health-related quality of life of patients | Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 | up to the 36-month period following treatment | 
| Survival time of patients in this study | Survival time was defined as from the date of diagnosis until death or the end of this study | up to the 36-month period following treatment | 
| Changes in Symptoms of patients using MD Anderson Symptoms Inventory Gastrointestinal Cancer Module (MDASI ) | MDASI contains a 24-item questionnaire. MDASI-GI symptom items are assessed on a numeric scale ranging from 0 or not present to 10 or as bad as you can imagine. The MDASI is a concise, internally stable, and sensitive tool for measuring multiple-symptom severity and symptom interference with function in patients with cancer. | up to the 36-month period following treatment |