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

NCT07258160 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2026-01-09

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PRaG-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.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Second Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2026-07-31
Completion
2026-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07258160 on ClinicalTrials.gov