Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer

February 23, 2026 updated by: PT. Prodia Stem Cell Indonesia

Safety and Efficacy of Adjuvant Therapy of Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer

The purpose of this study is to determine the safety and potential of dendritic cells therapy and secretomes therapy for advanced nasopharyngeal cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

There are three arms controlled group. First group receives standard medical theraphy (radiotherapy or chemoradiation), second group who receives autologous dendritic cell (Auto-DC), and third group receives the combination of allogenic-dendritic cell-secretomes (Allo-DC Secretome) and continued with autologous dendritic cell (Auto-DC).

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia
        • PT Prodia StemCell Indonesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients who tested positive EBV and confirmed suffering advanced nasopharyngeal cancer
  • Patients who have partial response or stable disease or progressive disease after performed standard therapy (radiology or chemoradiation) based on RECIST
  • Did not take traditional medicine in the last 2 months.
  • Patients can understand the nature of the study and willing to sign informed consent
  • Patients who received standard medical (radiology or chemoradiation) up to one additional therapy in the last 1 month.

Exclusion Criteria:

  • Patients who are pregnant, planning to pregnant, or breastfeeding
  • Patients assessed to require chemoradiation during this study
  • Patients who get complete score after undergo standard therapy (radiology or chemoradiation) based on the RECIST
  • Patients who have autoimun reaction, eczema, allergy or allergy history, and anaphylaxis
  • Patients who have creatinin clearance result <40 ml/min, bilirubin serum >1.5x above normal, SGPT-SGOT >5x above normal
  • Patients on immunosuppressive medications, such as corticosteroids
  • Patients who undergo Major thoracic or abdominal operation
  • Patients on high medical risk condition due to uncontrolled infection
  • Patients who diagnosed positive of Hepatitis B, Hepatitis C or Human Immunodeificiency virus (HIV)
  • Patients who have concurrent congestive heart failure history and other heart disease
  • Patients who have health conditions assessed by the doctor in charge cannot be included in this clinical trial
  • Patients who refuse or did not participate in part or all of the research process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo (Aqua Pro-Injection)
Subject will given 2 times injection of Aqua Pro-Injection via intramuscular (interval 2 days).
Other: Placebo (Aqua Pro-Injection)
Treatment with Aqua Pro-Injection 2 cc 2 times injection, interval 2 days (via Intramuscular).
Experimental: Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy)
Subject will given injection of Aqua Pro-Injection via intramuscular, two days after followed by Auto-DC via intramuscular.
Biological: Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy)
Treatment with Aqua Pro-Injection 2 cc, and then followed by Auto DC, interval 2 days (via Intramuscular)
Experimental: Combination of Auto DC and Allo-DC-Secretome
Subject will given injection of Allo-DC-Secretome via intramuscular, two days after followed by Auto-DC via intramuscular.
Biological: Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy)
Treatment with Allo-DC-Secretome 2 cc, and then followed by Auto DC, interval 2 days (via Intramuscular)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Karnofsky Performance Status
Time Frame: Before therapy
To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100.
Before therapy
Karnofsky Performance Status
Time Frame: 1 week after therapy
To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100.
1 week after therapy
Karnofsky Performance Status
Time Frame: 1 month after therapy
To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100.
1 month after therapy
Karnofsky Performance Status
Time Frame: 3 months after therapy
To measure the patient's Quality of Life. Karnofsky Performance Status can be used to determine patient's prognosis and measured changes of patient's ability to do daily activities which ranges from 0-100.
3 months after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PT. Prodia Stem Cell Indonesia

Investigators

  • Study Chair: Rima Haifa, B.Sc, Prodia Stem Cell Indonesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2022

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

February 20, 2022

First Submitted That Met QC Criteria

February 20, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/NPC/PSI/2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nasopharyngeal Cancer

Clinical Trials on Placebo (Aqua Pro-Injection)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe