Solid CancerPhase 2NCT07258160
Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors
A Phase 2 study testing PRaG-1 in people with Solid Cancer and Lymphopenia, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancer, Lymphopenia
- What is being tested?
- PRaG-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years;
- 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);
- No treatment with immunomodulatory or immunosuppressive agents within the past 2 weeks prior to enrollment;
- ECOG performance status score of 0-1, with an estimated life expectancy of ≥ 3 months;
- AST and ALT ≤ 3.0 times the upper limit of normal (ULN) within one week prior to study enrollment; serum creatinine ≤ 2 times ULN;
- Ability to understand the study and voluntarily provide written informed consent.
Who cannot join
- 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;
- 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;
- 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;
- History of allergy to fungi, or to any of the following components: Cordyceps militaris extract powder, D-mannitol, maltitol, microcrystalline cellulose, or magnesium stearate;
- 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;
- Acute gout flare
- Any other condition deemed unsuitable for enrollment by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Junjun Zhang, 051267784829, sudazhangjunjun@126.com
About this study
Official title: Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors: A Randomized Withdrawal Trial
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.
Read more
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.
Read the detailed description
Cordycepin: 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.
This study is a multicenter, prospective, placebo-controlled, two-stage sequential design, randomized withdrawal trial. Patients with CD8+ lymphocytopenia who have been tumor-free for more than six months following the completion of radiotherapy and/or chemotherapy were screened. All patients first received open-label PRaG-1 at a dose of one tablet in the morning and one tablet in the evening for 14 days. Patients whose CD8+ lymphocytes increased by more than 25% were defined as treatment responders and entered the randomized withdrawal phase. The study population was enrolled in two stages into the open-label phase and then randomized accordingly. The alpha level for the two-stage testing was allocated using the Pocock method (both stages at 0.029). In the first stage, 80 subjects were enrolled in the open-label phase, and 48 of them entered the withdrawal trial. If the first stage met the superiority hypothesis, the trial would terminate; otherwise, it would proceed to the second stage. In the second stage, 47 subjects were enrolled in the open-label phase, and 28 of them entered the withdrawal trial. Data from both stages were combined for the final superiority test. Centralized randomization was used in both stages, with patients assigned in a 1:1 ratio to continue receiving PRaG-1 or to receive a placebo at one tablet in the morning and one tablet in the evening for 14 days. Peripheral blood lymphocyte subpopulations were measured on the day before treatment (baseline), and on Days 7, 14, 21, and 28 of the treatment period. The primary endpoint was the proportion of patients whose CD8+ lymphocytes decreased by more than 25% from baseline after the withdrawal period. Secondary endpoints included lymphocyte dynamics during the entire treatment period and quality of life scores. Safety endpoints included adverse events occurring during treatment and within four weeks after treatment, which were graded according to the CTCAE 5.0 criteria.
- Conditions
- Solid Cancer, Lymphopenia
- Being tested
- PRaG-1, Placebo
- Medical subject headings
- Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRaG-1Drug
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.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| PRaG-1 | Experimental | Not described Receives: Drug: PRaG-1 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change in CD8+ Proportion of Participants with >25% Decline in CD8+ Lymphocyte During the Withdrawal Period (measured by flow cytometry)
Measured: 2 weeks
Secondary outcomes (1)
CD8+ Lymphocyte Response Over Time
Peripheral blood CD8+ T cell percentage measured by flow cytometry at baseline, week 1, week 2, and week 4
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Dec 2025
- Primary completionJul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258160
- Sponsor's protocol ID
- JD-LK2025016-A03
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors: A Randomized Withdrawal Trial
- ClinicalTrials.gov ID
- NCT07258160
- Acronym / sponsor ID
- JD-LK2025016-A03
- Conditions
- Solid Cancer, Lymphopenia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cordycepin: 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.
This study is a multicenter, prospective, placebo-controlled, two-stage sequential design, randomized withdrawal trial. Patients with CD8+ lymphocytopenia who have been tumor-free for more than six months following the completion of radiotherapy and/or chemotherapy were screened. All patients first received open-label PRaG-1 at a dose of one tablet in the morning and one tablet in the evening for 14 days. Patients whose CD8+ lymphocytes increased by more than 25% were defined as treatment responders and entered the randomized withdrawal phase. The study population was enrolled in two stages into the open-label phase and then randomized accordingly. The alpha level for the two-stage testing was allocated using the Pocock method (both stages at 0.029). In the first stage, 80 subjects were enrolled in the open-label phase, and 48 of them entered the withdrawal trial. If the first stage met the superiority hypothesis, the trial would terminate; otherwise, it would proceed to the second stage. In the second stage, 47 subjects were enrolled in the open-label phase, and 28 of them entered the withdrawal trial. Data from both stages were combined for the final superiority test. Centralized randomization was used in both stages, with patients assigned in a 1:1 ratio to continue receiving PRaG-1 or to receive a placebo at one tablet in the morning and one tablet in the evening for 14 days. Peripheral blood lymphocyte subpopulations were measured on the day before treatment (baseline), and on Days 7, 14, 21, and 28 of the treatment period. The primary endpoint was the proportion of patients whose CD8+ lymphocytes decreased by more than 25% from baseline after the withdrawal period. Secondary endpoints included lymphocyte dynamics during the entire treatment period and quality of life scores. Safety endpoints included adverse events occurring during treatment and within four weeks after treatment, which were graded according to the CTCAE 5.0 criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRaG-1 | Experimental | Drug: PRaG-1 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years;
- 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);
- No treatment with immunomodulatory or immunosuppressive agents within the past 2 weeks prior to enrollment;
- ECOG performance status score of 0-1, with an estimated life expectancy of ≥ 3 months;
- AST and ALT ≤ 3.0 times the upper limit of normal (ULN) within one week prior to study enrollment; serum creatinine ≤ 2 times ULN;
Key exclusion criteria (7 listed)
- 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;
- 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;
- 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;
- History of allergy to fungi, or to any of the following components: Cordyceps militaris extract powder, D-mannitol, maltitol, microcrystalline cellulose, or magnesium stearate;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRaG-1The 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 | PRaG-1 |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
Percentage Change in CD8+ Proportion of Participants with >25% Decline in CD8+ Lymphocyte During the Withdrawal Period (measured by flow cytometry)
Time frame: 2 weeks
1 secondary outcome
CD8+ Lymphocyte Response Over Time
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PRaG-1 in people with Solid Cancer and Lymphopenia, run by Second Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liyuan Zhang, Doctor (0512-67784829, zhangliyuan126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in CD8+ Proportion of Participants with >25% Decline in CD8+ Lymphocyte During the Withdrawal Period (measured by flow cytometry) (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.