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

September 6, 2023 updated by: Shanghai Cell Therapy Group Co.,Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Concentration of double antibodies in peripheral blood
Time Frame: Up to 3 months
Up to 3 months
Concentration of NMN (nicotinamide mononucleotide) in peripheral blood
Time Frame: Up to 3 months
Up to 3 months
Peripheral blood NAD+
Time Frame: Up to 3 months
Up to 3 months
Cytokines (IL6, TNF- goat, INF- γ, IL-4, IL-10)
Time Frame: Up to 3 months
Up to 3 months
T cell depletion index (PD1/Tim-3/lag3)
Time Frame: Up to 3 months
Up to 3 months
T cell activation index CD107
Time Frame: Up to 3 months
Up to 3 months
T cell and NK cell function index (INF- γ) and granzyme
Time Frame: Up to 3 months
Up to 3 months
High quality Survival benefit Endpoint (DFS)
Time Frame: 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.
Up to 15 years
Survival benefit (OS)
Time Frame: 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.
Up to 15 years
Distant Metastasis-Free Survival (DMFS)
Time Frame: Up to 15 years
Metastasis-free survival time. Patients need to be followed up regularly to keep records.
Up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Cell Therapy Group Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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