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

NCT06036355 | Unknown Early Phase 1 DMC

• 1 other identifier: CH2301-A-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Prevention of Tumor

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (1)

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.

Drug: Oral NMN combined with DC cell vaccine

Interventions

Oral NMN combined with DC cell vaccine DRUG

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.

Orally take NMN (Vital NAD) combined with DC cell vaccine injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 18-80 years old, weight ≥ 40kg.
• \. Patients with malignant solid tumors diagnosed by histology or cytology, who underwent radical resection and completed standard postoperative adjuvant therapy.
• \. Estimated survival time ≥ 6 months.
• \. ECOG score 0-1.
• \. Adequate venous channels, there is no contraindication for peripheral blood monocyte collection.
• \. Good function of organs and bone marrow.

You may not qualify if:

• \. Diabetes.
• \. Premenopausal or menopause \<1 year.
• \. Persons who have received hormone replacement therapy within the past 6 months.
• \. Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
• \. Unstable weight (\>3% change during the last 2 months before entering the study).
• \. Significant organ system dysfunction or disease.
• \. Polycystic ovary syndrome.
• \. Major psychiatric illness.
• \. 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.
• \. Metal implants.
• \. Persons who consume \>14 units of alcohol per week.
• \. 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.

Sponsors & Collaborators

• Shanghai Cell Therapy Group Co.,Ltd: lead

Study Sites (1)

Shanghai Mengchao Cancer Hospital

Shanghai, Shanghai Municipality, 200240, China

Location

Central Study Contacts

Jinxing Lou

CONTACT

+86-18911335396; loujx@shcell.com

Shuan Liu

CONTACT

+8617749122881; liushuan@shcell.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 13, 2023
• Study Start: September 30, 2023
• Primary Completion: April 30, 2024
• Study Completion: December 30, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

CN (1)