study of f527 in patients with relapsed or refractory lymphoma

Conditions: Relapsed/Refractory Lymphoma

Summary: this study is a non-randomized, open-label, phase i dose-finding and dose-expansion study to evaluate the safety, tolerability, antitumor efficacy, pk and immunogen of f527 in patients with relapsed or refractory lymphoma sexual characteristics.


Eligibility criteria:
inclusion criteria: 1. male or female aged ≥18 and ≤80 years old; 2. patients with histopathologically confirmed relapsed/refractory lymphoma; relapsed/refractory was defined as a patient who did not achieve a response (including complete or partial response) after the last systemic therapy regimen, or had disease progression after achieving a response or relapse; 3. subjects must have at least one measurable lesion assessed by the investigator (long diameter of lymph node\>15mm, long diameter of extranodal lesion\>10mm); 4. eastern cooperative oncology group (ecog) performance status (ps) score of 0-2; 5. expected survival period ≥ 3 months; 6. the function of vital organs meets the following requirements (do not use any blood components and cytokines within 7 days before the first dose): blood routine: neutrophil count ≥1.5×109/l; platelet count ≥75×109/l; hemoglobin ≥95g/l; liver function: tbil≤1.5×uln, alt and ast≤2.5×uln; if there is liver metastasis, alt and ast≤5×uln; renal function: creatinine≤1.5×uln; coagulation function: international normalized ratio (inr)≤1.5×uln and activated partial thromboplastin time (aptt)≤1.5×uln; 7. understand the test procedures and content, and sign the informed consent voluntarily. exclusion criteria: 1. special types of lymphoma such as primary/secondary central nervous system lymphoma, etc.; 2. patients with a history of other malignant tumors within the past 5 years, except for locally curable cancers (such as basal cell or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast, etc.); 3. history of hemolytic anemia or evans syndrome in the last three months; 4. positive direct antiglobulin test; 5. those who have used cd47-targeted drugs or signal-regulated protein alpha (sirpα)-targeted drugs in the past; 6. received anti-tumor-related treatments such as anti-tumor chemotherapy, radiotherapy, biological therapy, or immunotherapy/immunomodulation therapy within 2 weeks before the first administration; the toxicity of previous anti-tumor therapy has not recovered to ≤ grade 1 (except for alopecia); 7. patients who have a history of organ transplantation or allogeneic bone marrow transplantation, or who have received autologous stem cell transplantation within 3 months before the first administration or have other severe immunodeficiency; 8. hiv positive patients, syphilis-infected patients (rpr positive and tppa positive) or active hepatitis (hbsag positive and/or hbcab positive, and hbv-dna positive or higher than the upper limit of normal; hcv antibody positive and hcv- rna positive or above the upper limit of normal); 9. patients with uncontrollable or severe cardiovascular disease, who have new york heart association (nyha) class ii or above congestive heart failure, unstable angina, myocardial infarction and other cardiovascular diseases within 6 months before the first administration; uncontrolled hypertension (systolic blood pressure ≥180mmhg and/or diastolic blood pressure ≥100mmhg); 10. patients who have received any other clinical trial drug treatment within 4 weeks before the first dose; 11. patients who have received live attenuated vaccine within 4 weeks before the first dose; 12. patients who have a history of severe allergies, or who are known to be allergic to macromolecular protein preparations/monoclonal antibodies and any components of the investigational drug; 13. patients with a history of mental illness or drug abuse; 14. pregnant or lactating women, female patients or male patient partners who plan to become pregnant during the study period to 6 months after the last dose, and are reluctant to use a medically recognized effective contraceptive method (such as an intrauterine device or an intrauterine device) during the trial. condoms); 15. patients who are judged by the investigator to be unsuitable for enrollment.