The Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Prevention of Tumor
• Intervention / Treatment: Drug: Oral NMN combined with DC cell vaccine

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jinxing Lou; Phone Number: +86-18911335396; Email: loujx@shcell.com
• Study Contact Backup: Name: Shuan Liu; Phone Number: +8617749122881; Email: liushuan@shcell.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200240
      • Shanghai Mengchao Cancer Hospital
      • Contact: Jinxing Lou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orally take NMN (Vital NAD) combined with DC cell vaccine injection; 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.	Drug: Oral NMN combined with DC cell vaccine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of double antibodies in peripheral blood		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
T cell depletion index (PD1/Tim-3/lag3)		Up to 3 months
T cell activation index CD107		Up to 3 months
T cell and NK cell function index (INF- γ) and granzyme		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.	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.	Up to 15 years
Distant Metastasis-Free Survival (DMFS)	Metastasis-free survival time. Patients need to be followed up regularly to keep records.	Up to 15 years

Collaborators and Investigators

• Sponsor: Shanghai Cell Therapy Group Co.,Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): September 30, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CH2301-A-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No