Immune Modulation With PRaG-1 Treatment

NCT07002502 | Not Yet Recruiting Phase 2

• 1 other identifier: LK2025016
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is a single-center, prospective, single-arm, Phase II clinical trial. Eligible patients with advanced solid malignant tumors will sign the informed consent form and undergo screening for enrollment. After enrollment, patients will receive oral administration of "PRaG-1" twice daily (morning and evening) for a total of 10 days. Peripheral blood lymphocyte tests will be performed before treatment, on day 5 post-treatment, and at the conclusion of treatment.

Conditions

Cancer; Solid Cancer

Outcome Measures

Primary Outcomes (1)

• Peripheral blood lymphocyte subsets

  the change of peripheral blood lymphocyte subsets

  10 days

Secondary Outcomes (1)

• Adverse event

  3 months

Study Arms (1)

PRaG-1 treatment

EXPERIMENTAL

Drug: PRaG-1(cordycepin tablet)

Interventions

PRaG-1(cordycepin tablet) DRUG

The "PRaG-1" cordycepin tablet involved in this clinical study is produced by Shengmingyuan Company, a subsidiary of the National Biochemical Engineering Research Center at Nanjing Tech University. It is an oral tablet, with each tablet containing 200 mg of cordycepin. The product has obtained a national food production license, and the production license number is SC11332019200201.

PRaG-1 treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a history of other malignant diseases within the past 5 years, except for curatively treated skin cancer and cervical carcinoma in situ; Patients with a history of uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders, which, in the judgment of the investigator, may impair the ability to sign the informed consent form or affect the patient's compliance with drug treatment; Clinically significant (i.e., active) cardiovascular disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or worse congestive heart failure, or severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months; Patients currently receiving immunosuppressive therapy; Known active major infections, or significant hematological, renal, metabolic, gastrointestinal, endocrine dysfunction, or other serious uncontrolled comorbid conditions, as determined by the investigator; Patients with hypersensitivity to any component of the investigational drugs; History of immunodeficiency, including positive HIV test results or other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immunologically related conditions requiring long-term oral steroid therapy; Other conditions deemed unsuitable for enrollment by the investigator.

You may not qualify if:

• Patients with a history of any other malignant diseases within the past 5 years are excluded, except for curatively treated skin cancer and cervical carcinoma in situ.
• Patients with a history of uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders are excluded if, in the judgment of the investigator, these conditions may impair the ability to sign the informed consent form or affect the patient's compliance with drug treatment.
• Clinically significant (active) cardiovascular disease is excluded, including symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or worse congestive heart failure, severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months.
• Patients currently receiving immunosuppressive therapy are excluded. Known active major infections are excluded, as are significant hematological, renal, metabolic, gastrointestinal, endocrine dysfunction, or other serious uncontrolled comorbid conditions, as determined by the investigator.
• Patients with hypersensitivity to any component of the investigational drugs are excluded.
• History of immunodeficiency is excluded, including positive HIV test results, other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immunologically related conditions requiring long-term oral steroid therapy.
• Other conditions deemed unsuitable for enrollment by the investigator are excluded.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Liyuan Zhang, Doctor

CONTACT

0512-67784829; zhangliyuan126@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2025
• First Posted: June 3, 2025
• Study Start: June 15, 2025
• Primary Completion: May 26, 2026
• Study Completion (Estimated): June 26, 2026
• Last Updated: June 10, 2025

Record last verified: 2025-05