Postoperative Prevention of TumorEarly Phase 1NCT06036355
The Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)
A Early Phase 1 study testing Oral NMN combined with DC cell vaccine in people with Postoperative Prevention of Tumor, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.
Trial summary
The main purpose of this study is to explore the PK/PD changes of NMN and DC cells after oral NMN combined with DC cells injection in patients after tumor surgery, and evaluate the biological age of adults, TCR diversity, SiRT1 expression level, SF-36 quality of life, OS, antigen specific immune response (TAA)… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Prevention of Tumor
- What is being tested?
- Oral NMN combined with DC cell vaccine
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2023to 30 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- 1. 18-80 years old, weight ≥ 40kg.
- 2. Patients with malignant solid tumors diagnosed by histology or cytology, who underwent radical resection and completed standard postoperative adjuvant therapy.
- 3. Estimated survival time ≥ 6 months.
- 4. ECOG score 0-1.
- 5. Adequate venous channels, there is no contraindication for peripheral blood monocyte collection.
- 6. Good function of organs and bone marrow.
Who cannot join
- 1. Diabetes.
- 2. Premenopausal or menopause <1 year.
- 3. Persons who have received hormone replacement therapy within the past 6 months.
- 4. Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
- 5. Unstable weight (>3% change during the last 2 months before entering the study).
- 6. Significant organ system dysfunction or disease.
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- 7. Polycystic ovary syndrome.
- 8. Major psychiatric illness.
- 9. Use of medications known to affect study outcome measures (e.g., steroid) or increase the risk of study procedures (e.g., anticoagulants) that cannot be temporarily discontinued for the study.
- 10. Metal implants.
- 11. Persons who consume >14 units of alcohol per week.
- 12. Unable or unwilling to follow the study protocol or who, for any reason, is considered an inappropriate candidate for the study by the research team.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mengchao Cancer Hospital
Shanghai, Shanghai Municipality, 200240
Jinxing Lou
About this study
Official title: THE Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)
The main purpose of this study is to explore the PK/PD changes of NMN and DC cells after oral NMN combined with DC cells injection in patients after tumor surgery, and evaluate the biological age of adults, TCR diversity, SiRT1 expression level, SF-36 quality of life, OS, antigen specific immune response (TAA), cytokines and so on. In this study, 20 postoperative tumor patients who meet the entry and excretion criteria were recruited to explore the clinical potential of NMN combined with DC cell vaccine.
- Conditions
- Postoperative Prevention of Tumor
- Being tested
- Oral NMN combined with DC cell vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral NMN combined with DC cell vaccineDrug
The whole intervention cycle was treated with NMN (Vital NAD) 600mg/day for at least 50 days. During this period, the first DC cell injection was given on the 10th day, and then another DC cell injection was given at 2 weeks, 4 weeks and 6 weeks after the first injection.
| Study group | Role | What they receive |
|---|---|---|
| Orally take NMN (Vital NAD) combined with DC cell vaccine injection | Experimental | The arm is a combination of two drugs. The first NMN is a precursor of NAD+, which is used orally. DC vaccine is a kind of immune cells expanded in vitro and used by injection. Receives: Drug: Oral NMN combined with DC cell vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of double antibodies in peripheral blood
Measured: Up to 3 months
Concentration of NMN (nicotinamide mononucleotide) in peripheral blood
Measured: Up to 3 months
Peripheral blood NAD+
Measured: Up to 3 months
Cytokines (IL6, TNF- goat, INF- γ, IL-4, IL-10)
Measured: Up to 3 months
T cell depletion index (PD1/Tim-3/lag3)
Measured: Up to 3 months
T cell activation index CD107
Measured: Up to 3 months
T cell and NK cell function index (INF- γ) and granzyme
Measured: Up to 3 months
High quality Survival benefit Endpoint (DFS)
DFS refers to the time from the beginning of treatment to the recurrence of the disease or the death of the patient. Patients need to be followed up regularly to keep records.
Measured: Up to 15 years
Survival benefit (OS)
OS refers to the time from the beginning of randomization to death (for any reason). Patients need to be followed up regularly to keep records.
Measured: Up to 15 years
Distant Metastasis-Free Survival (DMFS)
Metastasis-free survival time. Patients need to be followed up regularly to keep records.
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start30 Sep 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Prevention of TumorStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Cell Therapy Group Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036355
- Sponsor's protocol ID
- CH2301-A-03
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)
- ClinicalTrials.gov ID
- NCT06036355
- Acronym / sponsor ID
- CH2301-A-03
- Conditions
- Postoperative Prevention of Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Cell Therapy Group Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 13 Sep 2023 (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 main purpose of this study is to explore the PK/PD changes of NMN and DC cells after oral NMN combined with DC cells injection in patients after tumor surgery, and evaluate the biological age of adults, TCR diversity, SiRT1 expression level, SF-36 quality of life, OS, antigen specific immune response (TAA), cytokines and so on. In this study, 20 postoperative tumor patients who meet the entry and excretion criteria were recruited to explore the clinical potential of NMN combined with DC cell vaccine.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orally take NMN (Vital NAD) combined with DC cell vaccine injection | Experimental | Drug: Oral NMN combined with DC cell vaccineThe arm is a combination of two drugs. The first NMN is a precursor of NAD+, which is used orally. DC vaccine is a kind of immune cells expanded in vitro and used by injection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. 18-80 years old, weight ≥ 40kg.
- 2. Patients with malignant solid tumors diagnosed by histology or cytology, who underwent radical resection and completed standard postoperative adjuvant therapy.
- 3. Estimated survival time ≥ 6 months.
- 4. ECOG score 0-1.
- 5. Adequate venous channels, there is no contraindication for peripheral blood monocyte collection.
Key exclusion criteria (12 listed)
- 1. Diabetes.
- 2. Premenopausal or menopause <1 year.
- 3. Persons who have received hormone replacement therapy within the past 6 months.
- 4. Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
- 5. Unstable weight (>3% change during the last 2 months before entering the study).
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 |
|---|---|---|
| Oral NMN combined with DC cell vaccineThe whole intervention cycle was treated with NMN (Vital NAD) 600mg/day for at least 50 days. During this period, the first DC cell injection was given on the 10th day, and then another DC cell injection was given at 2 weeks, 4 weeks and 6 weeks after the first injection. | Drug | Orally take NMN (Vital NAD) combined with DC cell vaccine injection |
Primary outcome
Concentration of double antibodies in peripheral blood
Time frame: Up to 3 months
Concentration of NMN (nicotinamide mononucleotide) in peripheral blood
Time frame: Up to 3 months
Peripheral blood NAD+
Time frame: Up to 3 months
Cytokines (IL6, TNF- goat, INF- γ, IL-4, IL-10)
Time frame: Up to 3 months
T cell depletion index (PD1/Tim-3/lag3)
Time frame: Up to 3 months
T cell activation index CD107
Time frame: Up to 3 months
T cell and NK cell function index (INF- γ) and granzyme
Time frame: Up to 3 months
High quality Survival benefit Endpoint (DFS)
Time frame: Up to 15 years
DFS refers to the time from the beginning of treatment to the recurrence of the disease or the death of the patient. Patients need to be followed up regularly to keep records.
Survival benefit (OS)
Time frame: Up to 15 years
OS refers to the time from the beginning of randomization to death (for any reason). Patients need to be followed up regularly to keep records.
Distant Metastasis-Free Survival (DMFS)
Time frame: Up to 15 years
Metastasis-free survival time. Patients need to be followed up regularly to keep records.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oral NMN combined with DC cell vaccine in people with Postoperative Prevention of Tumor, run by Shanghai Cell Therapy Group Co.,Ltd at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinxing Lou (+86-18911335396, loujx@shcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of double antibodies in peripheral blood (time frame: Up to 3 months). The study lists 10 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 13 Sep 2023; AzTrials last refreshed its copy on 30 Oct 2026.