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.
• 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;
• 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.