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NCT Number: NCT05261750

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Nasopharyngeal Cancer Head and Neck Neoplasms Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

PT Prodia StemCell Indonesia

Jakarta, Indonesia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo (Aqua Pro-Injection)

Other

Treatment with Aqua Pro-Injection 2 cc 2 times injection, interval 2 days (via Intramuscular).

Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy)

Biological

Treatment with Aqua Pro-Injection 2 cc, and then followed by Auto DC, interval 2 days (via Intramuscular)

Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy)

Biological

Treatment with Allo-DC-Secretome 2 cc, and then followed by Auto DC, interval 2 days (via Intramuscular)

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

PT. Prodia Stem Cell Indonesia

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2022
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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