Autologous Immune Enhancement Therapy (AIET) for Cancer Patients

Patients With Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05520372
• Other study ID #: AIET_2022
• Status: Completed
• Phase: Phase 1
• Start date: January 1, 2016
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2022
• Source: Vinmec Research Institute of Stem Cell and Gene Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Patients With Cancer

Intervention

Combination Product:
• Autologous immune enhancement therapy (AIET) for cancer patients
Autologous NK cell and CD8 T cell therapy for cancer patients

Locations

Country	Name	City	State
Vietnam	Vinmec Research Institute of Stem Cell and Gene Technology	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Vinmec Research Institute of Stem Cell and Gene Technology

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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