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Autologous Immune Enhancement Therapy (AIET) for Cancer Patients

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05520372
Enrollment
60
Registered
2022-08-29
Start date
2016-01-01
Completion date
2021-12-30
Last updated
2022-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients With Cancer

Brief summary

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

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.

Interventions

COMBINATION_PRODUCTAutologous immune enhancement therapy (AIET) for cancer patients

Autologous NK cell and CD8 T cell therapy for cancer patients

Sponsors

Vinmec Research Institute of Stem Cell and Gene Technology
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Adverse events and serious adverse events (AEs or SAEs)up to the 36-month period following treatmentthe number of AEs or SAEs during and after Autologous Immune Enhancement Therapy (AIET)

Secondary

MeasureTime frameDescription
Changes in health-related quality of life of patientsup to the 36-month period following treatmentUsing the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0
Survival time of patients in this studyup to the 36-month period following treatmentSurvival time was defined as from the date of diagnosis until death or the end of this study
Changes in Symptoms of patients using MD Anderson Symptoms Inventory Gastrointestinal Cancer Module (MDASI )up to the 36-month period following treatmentMDASI 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.

Countries

Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026