The Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)
- Conditions
- Postoperative Prevention of Tumor
- Interventions
- Registration Number
- NCT06036355
- Lead Sponsor
- Shanghai Cell Therapy Group Co.,Ltd
- Brief 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), 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
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- 18-80 years old, weight ≥ 40kg.
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- Patients with malignant solid tumors diagnosed by histology or cytology, who underwent radical resection and completed standard postoperative adjuvant therapy.
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- Estimated survival time ≥ 6 months.
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- ECOG score 0-1.
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- Adequate venous channels, there is no contraindication for peripheral blood monocyte collection.
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- Good function of organs and bone marrow.
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- Diabetes.
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- Premenopausal or menopause <1 year.
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- Persons who have received hormone replacement therapy within the past 6 months.
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- Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
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- Unstable weight (>3% change during the last 2 months before entering the study).
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- Significant organ system dysfunction or disease.
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- Polycystic ovary syndrome.
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- Major psychiatric illness.
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- 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.
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- Metal implants.
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- Persons who consume >14 units of alcohol per week.
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- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Orally take NMN (Vital NAD) combined with DC cell vaccine injection Oral NMN combined with DC cell vaccine 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.
- Primary Outcome Measures
Name Time Method Distant Metastasis-Free Survival (DMFS) Up to 15 years Metastasis-free survival time. Patients need to be followed up regularly to keep records.
T cell depletion index (PD1/Tim-3/lag3) Up to 3 months Concentration of NMN (nicotinamide mononucleotide) in peripheral blood Up to 3 months Peripheral blood NAD+ Up to 3 months Cytokines (IL6, TNF- goat, INF- γ, IL-4, IL-10) Up to 3 months High quality Survival benefit Endpoint (DFS) 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.
Concentration of double antibodies in peripheral blood Up to 3 months Survival benefit (OS) 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.
T cell activation index CD107 Up to 3 months T cell and NK cell function index (INF- γ) and granzyme Up to 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Shanghai Mengchao Cancer Hospital
🇨🇳Shanghai, Shanghai, China