ThrombocytopeniaPhase 1NCT06521931
A Study of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Lymphoma or Solid Tumor Patients
A Phase 1 study testing PN20 in people with Thrombocytopenia, run by Chongqing Peg-Bio Biopharm Co., Ltd. at 6 sites in China.
Trial summary
The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with chemotherapy-induced thrombocytopenia (CID). The main questions it aims to answer are: Is PN20 safe in these patients? Could these patients potentially benefit from PN20 prevention? Participants will Receive… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopenia
- What is being tested?
- PN20
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesChina
- Study dates
- 6 Dec 2023to 13 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Aged ≥ 18 years, regardless of gender;
- Diagnosed with lymphoma or solid tumor by pathological histology or cytology examination;
- Currently receiving a 21-day chemotherapy regimen, using one or more of the following or similar drugs: gemcitabine; platinums, including carboplatin, nedaplatin, cisplatin, lobaplatin, etc.; anthracyclines, including doxorubicin, daunorubicin, epirubicin, etc.; taxanes, including paclitaxel, docetaxel, etc.; alkylating agents, including cyclophosphamide, ifosfamide, etc.;
- The current chemotherapy regimen should be consistent with that of the previous chemotherapy cycle before enrollment, including the type and dosage of the drugs, and no medication or dosage adjustments are allowed;
- Platelet count (PLT) was between 75 and 150×10^9/L (including the critical value) one day before the start of chemotherapy in the first treatment cycle or before enrollment;
- There was a decrease in PLT to 25×10^9/L≤ PLT <75×10^9/L during the previous chemotherapy cycle before enrollment;
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- Expected survival ≥ 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) Physical Score is ≤ 2;
- No fertility plan during the trial and within 6 months after the end of the follow-up, and agree to take medically recognized contraceptive measures (such as complete abstinence, condoms, contraceptive rings, ligation, drug contraception, etc.) to avoid pregnancy for themselves or their partners;
- Be able to understand the requirements and procedures of the protocol, voluntarily participate and sign the informed consent form.
Who cannot join
- With thrombocytopenia caused by non-chemotherapy within 6 months before screening, including but not limited to ethylenediaminetetraacetic acid (EDTA)-dependent pseudothrombocytopenia, hypersplenism, infection and bleeding;
- With other hematopoietic diseases other than lymphoma and chemotherapy induced thrombocytopenia, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome;
- The tumor has already undergone bone marrow invasion or metastasis;
- With active central nervous system metastasis (such as clinical symptoms, cerebral edema, requiring hormone intervention (excluding maintenance of low-dose hormones)), progression of brain metastasis, and carcinomatous meningitis. Subjects with previously treated brain metastases who meet the following conditions may participate in the study: clinical stability has been maintained for ≥ 2 months, and systemic hormone therapy (prednisone or other equivalent doses of hormones at a dose of >10 mg/day) has been discontinued for >4 weeks;
- Acute or active bleeding of clinical significance (such as gastrointestinal or central nervous system) within 7 days before screening;
- Have a history of any arteriovenous thrombosis within 6 months before screening;
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- Have a history of major cardiovascular disease within 6 months before screening (such as congestive heart failure (New York Heart Association (NYHA) heart function score III-IV), arrhythmias known to increase the risk of thromboembolic events (atrial fibrillation, etc.), coronary stent implantation, angioplasty or coronary artery bypass grafting);
- Accompanying diseases that the investigator believes the investigational drug may cause unnecessary risks of, such as: severe cardiovascular and cerebrovascular diseases, digestive system diseases, liver and kidney dysfunction diseases, or a family history of mental illness;
- Laboratory examination abnormalities during the screening period (baseline), such as:
- Blood biochemistry: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin ≥ 3 times the upper limit of normal (ULN) (if liver metastasis exists, ALT, AST, total bilirubin can be ≥ 5 × ULN); serum creatinine ≥ 1.5 × ULN;
- Blood routine: absolute neutrophil value <1.5×10^9/L; hemoglobin < 80 g/L;
- Abnormal electrocardiogram of clinical significance during screening or prolonged QT/QTc interval, such as QTcF ≥ 450ms (male) or 470ms (female); family history of QT prolongation;
- Active hepatitis B (hepatitis B virus titer > 1,000 copies/ml or 200IU/ml); hepatitis C virus infection (HCV-RNA Above the detection limit); preventive antiviral treatment other than interferon is allowed. For patients with hepatocellular carcinoma (HCC), hepatitis B virus titer> 10,000 copies/ml or 2000IU/ml; human immunodeficiency virus antibody (HIV), syphilis positive;
- Received platelet transfusion within 5 days before the first dose;
- Anticoagulants (heparin, warfarin, apixaban, bivalirudin, etc.), antiplatelet drugs (clopidogrel, aspirin, etc.), fibrinolytic drugs (urokinase, etc.) were used for prevention or treatment within 1 week before the first dose;
- Received other drugs with platelet-raising effects (e.g., caffeic acid tablets, leucogen tablets, aminopeptide tablets, or platelet-raising capsules, etc.) within 1 week before the first dose; received recombinant human thrombopoietin (rh-TPO) or used recombinant human interleukin-11 (rhIL-11), thrombopoietin receptor agonist (TPO-RA) within 10 days before the first dose or 5 half-lives of the drug (whichever is longer);
- Currently receiving or received radiotherapy within 3 months before screening;
- Received bone marrow transplantation or stem cell infusion within 1 year before screening;
- Allergic to the investigational drug or excipients (such as histidine, glycine, mannitol, sucrose) or previously experienced life-threatening systemic allergic reaction;
- Used other clinical trial drugs or devices within 4 weeks before the first dose;
- Other conditions the investigator believes would be unsuitable for participation in this clinical study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266057
Yiyang Central Hospital
Yiyang, Hunan, 413099
Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: A Single-arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Immunogenicity of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Patients With Lymphoma or Solid Tumor
The main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with chemotherapy-induced thrombocytopenia (CID). The main questions it aims to answer are:
- Is PN20 safe in these patients?
- Could these patients potentially benefit from PN20 prevention? Participants will
- Receive subcutaneous injections of PN20 according to weight on the first day of chemotherapy cycle, within 1 hour before the administration of chemotherapy drugs,
- Visit the clinic on Day 1 (D1), D2, D3, D4, D5, D8, D11, D13, D15 and D21 for assessment.
Read the detailed description
This is a multicenter, single-arm, open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamics and immunogenicity of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Adult Patients With Lymphoma or Solid Tumor.
This study was divided into two phase, single-dose and multiple-dose. After single-dose period (21 days), if the subject meets the multiple-dose criteria, he or she can enter the multiple-dose phase for the second cycle of PN20 prevention. Subjects could receive a maximum of two cycles of PN20 prevention.
- Conditions
- Thrombocytopenia
- Being tested
- PN20
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PN20Drug
Three dose cohorts: 0.2, 0.5 and 0.75 mg/kg, subcutaneous injections, on Day 1 of chemotherapy cycle before the administration of chemotherapy drugs
| Study group | Role | What they receive |
|---|---|---|
| PN20 group | Experimental | thrombopoietin receptor agonist Receives: Drug: PN20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE in single-dose phase
The incidence of adverse events related to PN20 within 21 days after a single dose
Measured: Day 1-21 of Cycle 1 (each cycle is 21 days)
The proportion of patients with PLT ≥ 100×10^9/L in multiple-dose phase
The proportion of subjects whose platelet count (PLT) reached ≥ 100 × 10^9/L at the end of the second chemotherapy cycle.
Measured: Day 21 of Cycle 2 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start6 Dec 2023
- Primary completion13 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombocytopeniaStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Suxia Luo, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521931
- Sponsor's protocol ID
- CQPJ-PN20-Ib
- Status last verified
- Feb 2026
- First submitted
- 18 Jul 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Immunogenicity of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Patients With Lymphoma or Solid Tumor
- ClinicalTrials.gov ID
- NCT06521931
- Acronym / sponsor ID
- CQPJ-PN20-Ib
- Conditions
- Thrombocytopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Chongqing Peg-Bio Biopharm Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Dec 2023 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 26 Jul 2024 (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 main aim of this clinical trial is to assess the safety and tolerability of PN20 in adult patients with chemotherapy-induced thrombocytopenia (CID). The main questions it aims to answer are:
- Is PN20 safe in these patients?
- Could these patients potentially benefit from PN20 prevention? Participants will
- Receive subcutaneous injections of PN20 according to weight on the first day of chemotherapy cycle, within 1 hour before the administration of chemotherapy drugs,
- Visit the clinic on Day 1 (D1), D2, D3, D4, D5, D8, D11, D13, D15 and D21 for assessment.
Detailed description
This is a multicenter, single-arm, open-label, dose escalation study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamics and immunogenicity of PN20 for the Prevention of Chemotherapy-induced Thrombocytopenia in Adult Patients With Lymphoma or Solid Tumor.
This study was divided into two phase, single-dose and multiple-dose. After single-dose period (21 days), if the subject meets the multiple-dose criteria, he or she can enter the multiple-dose phase for the second cycle of PN20 prevention. Subjects could receive a maximum of two cycles of PN20 prevention.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PN20 group | Experimental | Drug: PN20thrombopoietin receptor agonist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged ≥ 18 years, regardless of gender;
- Diagnosed with lymphoma or solid tumor by pathological histology or cytology examination;
- Currently receiving a 21-day chemotherapy regimen, using one or more of the following or similar drugs: gemcitabine; platinums, including carboplatin, nedaplatin, cisplatin, lobaplatin, etc.; anthracyclines, including doxorubicin, daunorubicin, epirubicin, etc.; taxanes, including paclitaxel, docetaxel, etc.; alkylating agents, including cyclophosphamide, ifosfamide, etc.;
- The current chemotherapy regimen should be consistent with that of the previous chemotherapy cycle before enrollment, including the type and dosage of the drugs, and no medication or dosage adjustments are allowed;
- Platelet count (PLT) was between 75 and 150×10^9/L (including the critical value) one day before the start of chemotherapy in the first treatment cycle or before enrollment;
Key exclusion criteria (21 listed)
- With thrombocytopenia caused by non-chemotherapy within 6 months before screening, including but not limited to ethylenediaminetetraacetic acid (EDTA)-dependent pseudothrombocytopenia, hypersplenism, infection and bleeding;
- With other hematopoietic diseases other than lymphoma and chemotherapy induced thrombocytopenia, including leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome;
- The tumor has already undergone bone marrow invasion or metastasis;
- With active central nervous system metastasis (such as clinical symptoms, cerebral edema, requiring hormone intervention (excluding maintenance of low-dose hormones)), progression of brain metastasis, and carcinomatous meningitis. Subjects with previously treated brain metastases who meet the following conditions may participate in the study: clinical stability has been maintained for ≥ 2 months, and systemic hormone therapy (prednisone or other equivalent doses of hormones at a dose of >10 mg/day) has been discontinued for >4 weeks;
- Acute or active bleeding of clinical significance (such as gastrointestinal or central nervous system) within 7 days before screening;
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 |
|---|---|---|
| PN20Three dose cohorts: 0.2, 0.5 and 0.75 mg/kg, subcutaneous injections, on Day 1 of chemotherapy cycle before the administration of chemotherapy drugs | Drug | PN20 group |
Primary outcome
AE in single-dose phase
Time frame: Day 1-21 of Cycle 1 (each cycle is 21 days)
The incidence of adverse events related to PN20 within 21 days after a single dose
The proportion of patients with PLT ≥ 100×10^9/L in multiple-dose phase
Time frame: Day 21 of Cycle 2 (each cycle is 21 days)
The proportion of subjects whose platelet count (PLT) reached ≥ 100 × 10^9/L at the end of the second chemotherapy cycle.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 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. This study is not recruiting at the moment.
Suxia Luo principal investigator
Henan Cancer Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PN20 in people with Thrombocytopenia, run by Chongqing Peg-Bio Biopharm Co., Ltd. at 6 sites 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 10 inclusion and 21 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: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE in single-dose phase (time frame: Day 1-21 of Cycle 1 (each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 2 Mar 2026.