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Completed

NCT Number: NCT05520372

Autologous Immune Enhancement Therapy (AIET) for Cancer Patients

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

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Key information

Conditions

Patients With Cancer

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous immune enhancement therapy (AIET) for cancer patients

Combination Product

Autologous NK cell and CD8 T cell therapy for cancer patients

Primary outcomes

  1. Number of Adverse events and serious adverse events (AEs or SAEs)

    Time frame: up to the 36-month period following treatment

    the number of AEs or SAEs during and after Autologous Immune Enhancement Therapy (AIET)

Secondary outcomes

  1. Changes in health-related quality of life of patients

    Time frame: up to the 36-month period following treatment

    Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0

  2. Survival time of patients in this study

    Time frame: up to the 36-month period following treatment

    Survival time was defined as from the date of diagnosis until death or the end of this study

  3. Changes in Symptoms of patients using MD Anderson Symptoms Inventory Gastrointestinal Cancer Module (MDASI )

    Time frame: up to the 36-month period following treatment

    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.

Sponsors and collaborators

Lead sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Aug 29, 2022
Registry last updated
Aug 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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