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

Phase 1

Recruiting

• Conditions: Nasopharyngeal Cancer
• Interventions: Biological: Allo-Dendritic-Secretome Adjuvant Therapy; Biological: Auto-Dendritic Adjuvant Therapy

• Registration Number: NCT05261750
• Lead Sponsor: PT. Prodia Stem Cell Indonesia

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.

Detailed Description

There are controlled group who receives standard medical theraphy (radiotherapy or chemoradiation), one group who receives standard medical theraphy (radiotherapy or chemoradiation) and Auto-dendritic adjuvant therapy, and other group who receives standard medical theraphy (radiotherapy or chemoradiation) and Allo-dendritic-secretomes adjuvant therapy and continued with auto-dendritic therapy.

Study Timeline

• Study First Submitted: 2022-02-20
• Study First Submitted QC: 2022-02-20
• Study First Posted: 2022-03-02
• Study Start: 2022-04-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-23
• Last Update Posted: 2022-09-26
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Allo-Dendritic-secretome and Auto-Dendritic Adjuvant Therapy	Allo-Dendritic-Secretome Adjuvant Therapy	Patients will be given standrad medical therapy (radiotherapy or chemoradiation) and allo-dendritic-secretome adjuvant therapy 2 cc 1 times injection, and then followed by auto-dendritic therapy via intramuscular 3 times injection every 1 week.
Auto-Dendritic Adjuvant Therapy	Auto-Dendritic Adjuvant Therapy	Patients will be given standard medical therapy (radiotherapy or chemoradiation) and auto-dendritic adjuvant therapy via intramuscular 3 times injection every 1 week.

Primary Outcome Measures

Name	Time	Method
Karnofsky Performance Status	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.

Trial Locations

Locations (1)

PT Prodia StemCell Indonesia; 🇮🇩 Jakarta, Indonesia