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

NCT ID: NCT06036355

Last Updated: 2023-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-12-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Oral NMN combined with DC cell vaccine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Cell Therapy Group Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Mengchao Cancer Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jinxing Lou

Role: CONTACT

loujx@shcell.com

+86-18911335396

Shuan Liu

Role: CONTACT

liushuan@shcell.com

+8617749122881

Facility Contacts

Jinxing Lou

Role: primary

Other Identifiers

CH2301-A-03

Identifier Type: -

Identifier Source: org_study_id