Autologous Immune Enhancement Therapy (AIET) for Cancer Patients

Phase 1

Completed

• Conditions: Patients With Cancer
• Interventions: Combination Product: Autologous immune enhancement therapy (AIET) for cancer patients

• Registration Number: NCT05520372
• Lead Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-08
• Study First Submitted: 2022-08-23
• Study First Submitted QC: 2022-08-25
• Last Update Submitted: 2022-08-25
• Study First Posted: 2022-08-29
• Last Update Posted: 2022-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
autologous immune enhancement therapy (AIET) for treating cancer	Autologous immune enhancement therapy (AIET) for cancer patients	A total of 60 cancer patients received one to seven sittings of natural killer (NK) cells and cytotoxic T lymphocytes (CTLs) infusions.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in health-related quality of life of patients	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
Survival time of patients in this study	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
Changes in Symptoms of patients using MD Anderson Symptoms Inventory Gastrointestinal Cancer Module (MDASI )	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.

Trial Locations

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology; 🇻🇳 Hanoi, Vietnam