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

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

Study Overview

• Status: Completed
• Conditions: Patients With Cancer
• Intervention / Treatment: Combination product: Autologous immune enhancement therapy (AIET) for cancer patients

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • Vinmec Research Institute of Stem Cell and Gene Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: autologous immune enhancement therapy (AIET) for treating cancer; 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; Autologous NK cell and CD8 T cell therapy for cancer patients

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
• Investigators: Principal Investigator: Liem Nguyen Thanh, PhD, Vinmec Research Institute of Stem Cell and Gene Technology

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: August 23, 2022
• First Submitted That Met QC Criteria: August 25, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: AIET_2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No