NCT05520372

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2022

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

6 years

First QC Date

August 23, 2022

Last Update Submit

August 25, 2022

Conditions

Patients With Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Changes in health-related quality of life of patients

    up to the 36-month period following treatment

  • Survival time of patients in this study

    up to the 36-month period following treatment

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

    up to the 36-month period following treatment

Study Arms (1)

autologous immune enhancement therapy (AIET) for treating cancer

EXPERIMENTAL

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

Interventions

Autologous immune enhancement therapy (AIET) for cancer patientsCOMBINATION_PRODUCT

Autologous NK cell and CD8 T cell therapy for cancer patients

autologous immune enhancement therapy (AIET) for treating cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 - 75
  • Patients have been diagnosed with cancer.
  • Patients signed the written informed consent form.

You may not qualify if:

  • Severe health conditions such as serious infection, autoimmune diseases, or using any anti-rejection drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, 100000, Vietnam

Location

Study Officials

  • Liem Nguyen Thanh, PhD

    Vinmec Research Institute of Stem Cell and Gene Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2022

First Posted

August 29, 2022

Study Start

January 1, 2016

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

August 29, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

VN(1)