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

Sponsor
Shanghai Cell Therapy Group Co.,Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06036355
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
15
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Oral NMN combined with DC cell vaccine
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
THE Exploratory Study on the Biological Function of Dendritic Cells In Vivo Supported by Nicotinamide Mononucleotide (Vital NAD)
Anticipated Study Start Date :
Sep 30, 2023
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Concentration of double antibodies in peripheral blood [Up to 3 months]

  2. Concentration of NMN (nicotinamide mononucleotide) in peripheral blood [Up to 3 months]

  3. Peripheral blood NAD+ [Up to 3 months]

  4. Cytokines (IL6, TNF- goat, INF- γ, IL-4, IL-10) [Up to 3 months]

  5. T cell depletion index (PD1/Tim-3/lag3) [Up to 3 months]

  6. T cell activation index CD107 [Up to 3 months]

  7. T cell and NK cell function index (INF- γ) and granzyme [Up to 3 months]

  8. 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.

  9. 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.

  10. Distant Metastasis-Free Survival (DMFS) [Up to 15 years]

    Metastasis-free survival time. Patients need to be followed up regularly to keep records.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. 18-80 years old, weight ≥ 40kg.
    1. Patients with malignant solid tumors diagnosed by histology or cytology, who underwent radical resection and completed standard postoperative adjuvant therapy.
    1. Estimated survival time ≥ 6 months.
    1. ECOG score 0-1.
    1. Adequate venous channels, there is no contraindication for peripheral blood monocyte collection.
    1. Good function of organs and bone marrow.
Exclusion Criteria:
    1. Diabetes.
    1. Premenopausal or menopause <1 year.
    1. Persons who have received hormone replacement therapy within the past 6 months.
    1. Persons who take vitamin B supplementation and are not willing to discontinue supplementation for 3 weeks before and during the entire study period.
    1. Unstable weight (>3% change during the last 2 months before entering the study).
    1. Significant organ system dysfunction or disease.
    1. Polycystic ovary syndrome.
    1. Major psychiatric illness.
    1. 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.
    1. Metal implants.
    1. Persons who consume >14 units of alcohol per week.
    1. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai Mengchao Cancer Hospital Shanghai Shanghai China 200240

Sponsors and Collaborators

  • Shanghai Cell Therapy Group Co.,Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Cell Therapy Group Co.,Ltd
ClinicalTrials.gov Identifier:
NCT06036355
Other Study ID Numbers:
  • CH2301-A-03
First Posted:
Sep 13, 2023
Last Update Posted:
Sep 13, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 13, 2023