NCT07002502

Immune Modulation With PRaG-1 Treatment

Immune Modulation and Efficacy Assessment of PRaG-1 in Patients With Advanced Solid Malignancies: A Prospective, Multicenter, Open-Label Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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. Patients will receive "PRaG-1" treatment twice daily (morning and evening) for a total of 10 days. Peripheral blood lymphocyte tests will be performed at pre-treatment, after 5 days of treatment, and at the end of treatment. A 5 ml blood sample and 2 g of tissue will be collected via biopsy before and after treatment for storage, to be used in subsequent analysis of immune function-related indicators. The clinical trial will be terminated if any of the following occur: disease progression, intolerable toxicity, withdrawal of the informed consent form (ICF), death, or other conditions specified in the protocol that require discontinuation of treatment.

Conditions

• Cancer
• Solid Cancer

Interventions

Type	Name	Description
DRUG	PRaG-1(cordycepin tablet)	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.

Timeline

• Start date: 2025-06-15
• Primary completion: 2026-05-26
• Completion: 2026-06-26
• First posted: 2025-06-03
• Last updated: 2025-06-10