Nasopharyngeal CancerPhase 1/2NCT05261750
Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer
A Phase 1/2 study testing Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy) and Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy) in people with Nasopharyngeal Cancer, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
Trial summary
The purpose of this study is to determine the safety and potential of dendritic cells therapy and secretomes therapy for advanced nasopharyngeal cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nasopharyngeal Cancer
- What is being tested?
- Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy) and Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Apr 2022to 28 Feb 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Nasopharyngeal Cancer
- Being tested
- Placebo (Aqua Pro-Injection), Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy), Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy)
- Keywords
- Dendritic Cells, Dendritic Secretomes
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Aqua Pro-Injection) | Placebo comparator | Subject will given 2 times injection of Aqua Pro-Injection via intramuscular (interval 2 days). Receives: 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. Receives: 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. Receives: Biological: Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start30 Apr 2022
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CancerStudies of the same condition, open and under way.
- More trials run by PT. Prodia Stem Cell IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PT. Prodia Stem Cell Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rima Haifa, B.Sc, Study chair, Prodia Stem Cell Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261750
- Sponsor's protocol ID
- CT/NPC/PSI/2022
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2022
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Adjuvant Therapy of Autologous Dendritic Cells and Allogenic Dendritic Secretomes for Patients With Advanced Nasopharyngeal Cancer
- ClinicalTrials.gov ID
- NCT05261750
- Acronym / sponsor ID
- CT/NPC/PSI/2022
- Conditions
- Nasopharyngeal Cancer
- Keywords
- Dendritic Cells, Dendritic Secretomes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- PT. Prodia Stem Cell IndonesiaIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo (Aqua Pro-Injection) | Placebo comparator | Other: Placebo (Aqua Pro-Injection)Subject will given 2 times injection of Aqua Pro-Injection via intramuscular (interval 2 days). |
| Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy) | Experimental | Biological: 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. |
| Combination of Auto DC and Allo-DC-Secretome | Experimental | Biological: Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy)Subject will given injection of Allo-DC-Secretome via intramuscular, two days after followed by Auto-DC via intramuscular. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo (Aqua Pro-Injection)Treatment with Aqua Pro-Injection 2 cc 2 times injection, interval 2 days (via Intramuscular). | Other | Placebo (Aqua Pro-Injection) |
| 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) | Biological | Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy) |
| 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) | Biological | Combination of Auto DC and Allo-DC-Secretome |
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rima Haifa, B.Sc study chair
Prodia Stem Cell Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Auto-DC (Autologous Dendritic Cell as Adjuvant Therapy) and Combination of Auto DC and Allo-Dendritic Cell-Secretome (Allogeneic Dendritic Cell-Secretome as Adjuvant Therapy) in people with Nasopharyngeal Cancer, run by PT. Prodia Stem Cell Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Karnofsky Performance Status (time frame: Before therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.