Clinical trial NCT06036355: The Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)
Official title: THE Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Postoperative Prevention of Tumor
Lead sponsor: Shanghai Cell Therapy Group Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2023-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Concentration of double antibodies in peripheral blood
timeFrame: Up to 3 months
measure: Concentration of NMN (nicotinamide mononucleotide) in peripheral blood
timeFrame: Up to 3 months
measure: Peripheral blood NAD+
timeFrame: Up to 3 months
measure: Cytokines (IL6, TNF- goat, INF- γ, IL-4, IL-10)
timeFrame: Up to 3 months
measure: T cell depletion index (PD1/Tim-3/lag3)
timeFrame: Up to 3 months
measure: T cell activation index CD107
timeFrame: Up to 3 months
measure: T cell and NK cell function index (INF- γ) and granzyme
timeFrame: Up to 3 months
measure: High quality Survival benefit Endpoint (DFS)
timeFrame: Up to 15 years
measure: Survival benefit (OS)
timeFrame: Up to 15 years
measure: Distant Metastasis-Free Survival (DMFS)
timeFrame: Up to 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mengchao Cancer Hospital
state: Shanghai
Study officials:
References: