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

NCT05261750 | Active Not Recruiting Phase 1 DMC

• 1 other identifier: CT/NPC/PSI/2022
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Nasopharyngeal Cancer

Keywords

Dendritic Cells; Dendritic Secretomes

Outcome Measures

Primary Outcomes (4)

• Karnofsky Performance Status

  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

  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

  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

  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

Study Arms (3)

Placebo (Aqua Pro-Injection)

PLACEBO COMPARATOR

Subject will given 2 times injection of Aqua Pro-Injection via intramuscular (interval 2 days).

Other: Placebo (Aqua Pro-Injection)

Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy)

EXPERIMENTAL

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)

Combination of Auto DC and Allo-DC-Secretome

EXPERIMENTAL

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)

Interventions

Placebo (Aqua Pro-Injection) OTHER

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

Placebo (Aqua Pro-Injection)

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)

Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy)

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)

Combination of Auto DC and Allo-DC-Secretome

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• PT. Prodia Stem Cell Indonesia: lead

Study Sites (1)

PT Prodia StemCell Indonesia

Jakarta, Indonesia

Location

MeSH Terms

Conditions

Nasopharyngeal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Rima Haifa, B.Sc

  Prodia Stem Cell Indonesia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 2, 2022
• Study Start: April 30, 2022
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

ID (1)