Cordycepin (PRaG-1) to raise CD8+ T‑cell counts after treatment for solid tumors

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

This trial will test whether PRaG-1 (cordycepin) can raise low CD8+ T‑cell counts in adults who are tumor‑free after treatment for solid cancers.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 127 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital of Soochow University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT07258160 on ClinicalTrials.gov

What this trial studies

Adults with solid tumors who have been tumor‑free for at least six months and have low CD8+ counts first receive open‑label PRaG‑1 (one tablet morning and evening) for 14 days. Participants whose CD8+ counts increase by more than 25% are defined as responders and enter a 14‑day randomized withdrawal phase to either continue PRaG‑1 or switch to placebo. The study uses a two‑stage sequential design with Pocock alpha allocation to decide whether to stop after the first stage or proceed to a second stage. Safety and tolerability are monitored throughout with serial peripheral blood lymphocyte subpopulation testing and standard laboratory assessments.

Who should consider this trial

Good fit: Adults (≥18) with a confirmed solid malignancy who have been tumor‑free for more than six months after completing radiotherapy and/or chemotherapy, with peripheral blood CD8+ counts below the laboratory lower limit, ECOG 0–1, acceptable liver and kidney tests, no recent immunosuppressive therapy, and able to give informed consent.

Not a fit: Patients with active or progressive cancer, recent immunosuppressive or immunomodulatory treatment, uncontrolled CNS disease or epilepsy, severe organ dysfunction outside enrollment criteria, or other conditions judged by investigators to interfere with participation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, PRaG‑1 could help restore CD8+ T‑cell counts and support immune recovery in cancer survivors who have persistent lymphocytopenia.

How similar studies have performed: Preclinical studies and limited clinical reports suggest cordycepin has immunomodulatory effects, but randomized clinical evidence showing it raises CD8+ counts in post‑treatment cancer patients is limited and this withdrawal design is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years;
2. Participants with solid malignant tumors, with confirmed pathological diagnosis or medical history; they have completed radiotherapy and/or chemotherapy more than six months ago; and peripheral blood CD8+ absolute count (blood drawn before 10:00 AM) below the lower reference limit (LRL);
3. No treatment with immunomodulatory or immunosuppressive agents within the past 2 weeks prior to enrollment;
4. ECOG performance status score of 0-1, with an estimated life expectancy of ≥ 3 months;
5. AST and ALT ≤ 3.0 times the upper limit of normal (ULN) within one week prior to study enrollment; serum creatinine ≤ 2 times ULN;
6. Ability to understand the study and voluntarily provide written informed consent.

Exclusion Criteria:

1. History of uncontrolled epilepsy, central nervous system (CNS) disease, or mental disorders, as determined by the investigator to be clinically significant and potentially interfere with the participant's ability to provide informed consent or comply with medication;
2. Significant (i.e., active) cardiovascular disease, including symptomatic coronary heart disease, congestive heart failure classified as New York Heart Association (NYHA) Class II or worse, or serious arrhythmias requiring pharmacological intervention, or history of myocardial infarction within the past 12 months;
3. Known active serious infections, or in the investigator's opinion, presence of major hematological, renal, metabolic, gastrointestinal, or endocrine dysfunction, or other serious, uncontrolled comorbidities;
4. History of allergy to fungi, or to any of the following components: Cordyceps militaris extract powder, D-mannitol, maltitol, microcrystalline cellulose, or magnesium stearate;
5. History of immunodeficiency, including HIV positive status, or diagnosis with other acquired or congenital immunodeficiencies, or a history of organ transplantation, or immunological disorders requiring long-term oral corticosteroid treatment;
6. Acute gout flare
7. Any other condition deemed unsuitable for enrollment by the investigator.

Where this trial is running

Suzhou, Jiangsu

• The Second Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Liyuan Zhang, Doctor

Conditions: Solid Cancer, Lymphopenia