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

PT. Prodia Stem Cell Indonesia

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Nasopharyngeal Cancer

Treatments: Biological: Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy); Biological: Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy); Other: Placebo (Aqua Pro-Injection)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05261750

CT/NPC/PSI/2022

Details and patient eligibility

About

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

Full 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).

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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15 participants in 3 patient groups, including a placebo group

Placebo (Aqua Pro-Injection)

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo (Aqua Pro-Injection)

Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy)

Experimental group

Description:

Subject will given injection of Aqua Pro-Injection via intramuscular, two days after followed by Auto-DC via intramuscular.

Treatment:

Biological: Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy)

Combination of Auto DC and Allo-DC-Secretome

Experimental group

Description:

Subject will given injection of Allo-DC-Secretome via intramuscular, two days after followed by Auto-DC via intramuscular.

Treatment:

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