Study of PRaG-1 Cordycepin in Adults with Solid Tumors and Low CD8 Lymphocytes After Radiotherapy or Chemotherapy

What this Trial Is About

This trial evaluates the effects of PRaG-1, a cordycepin tablet, on improving CD8 lymphocytopenia in patients with solid tumors who have been tumor-free for over six months after completing radiotherapy or chemotherapy. The study aims to determine whether PRaG-1 increases CD8 lymphocyte counts by more than 25%, whether this effect persists after stopping treatment, and to assess the safety and tolerability of PRaG-1 in this population. Participants will take PRaG-1 orally, one tablet in the morning and one in the evening, for 14 days during an open-label phase. Those who respond with a CD8 lymphocyte increase over 25% will enter a 14-day randomized withdrawal phase where they will either continue PRaG-1 or switch to a placebo. Lymphocyte counts will be measured at baseline, and on days 7, 14, 21, and 28. Safety is monitored throughout and adverse events are recorded. Throughout the study, participants will have blood tests to measure lymphocyte levels, and their quality of life will be assessed. Safety monitoring follows established criteria for adverse events. Researchers will compare the immune response between those continuing treatment and those on placebo after withdrawal to determine if PRaG-1 maintains increased lymphocyte counts. The trial is expected to run until September 2026.

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