RecruitingPhase 2NCT07258160

Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors

Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors: A Randomized Withdrawal Trial


Sponsor

Second Affiliated Hospital of Soochow University

Enrollment

127 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the effectiveness of PRaG-1 in improving CD8+ lymphocytopenia in patients with solid tumors who are tumor-free for more than six months after completing radiotherapy and/or chemotherapy. It will also assess the safety of PRaG-1 Cordycepin in these patients. The main questions it aims to answer are: Does PRaG-1 increase CD8+ lymphocyte counts by more than 25% in this patient population? Does the effect of PRaG-1 maintain when treatment is discontinued? What are the safety and tolerability profiles of PRaG-1 during and after the treatment period? Participants will receive open-label PRaG-1 (one tablet in the morning and one in the evening) for 14 days, and those who show a response (CD8+ lymphocytes increase by more than 25%) will enter a 14-day randomized withdrawal period, where they will be assigned to continue PRaG-1 or switch to a placebo. Throughout the study, participants will: Have their peripheral blood lymphocyte subpopulations tested at baseline and on Days 7 and 14 Undergo safety monitoring for adverse events according to CTCAE 5.0 criteria Provide information on their quality of life during the treatment period Researchers will compare the outcomes of those who continue PRaG-1 to those who receive a placebo to determine if the observed improvement in CD8+ lymphocytes is sustained, which would indicate that the drug is effective in maintaining immune response.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PRaG-1 and a drug called Placebo for people with lymphopenia and solid cancer. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPRaG-1

The PRaG-1 cordycepin tablets used in this clinical study were produced by Shengmingyuan Company, which is affiliated with the National Bioprocess Engineering Research Center at Nanjing Tech University. The tablets are oral formulations containing 200 mg of cordycepin per tablet and have obtained national food production approval. The production license number is: SC11332019200201.

DRUGPlacebo

Placebo


Locations(1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT07258160


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