Relapsed/Refractory Lymphoma
Conditions
Brief 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.
Interventions
DRUGF527
0.001、0.01、0.1、0.3、1、3 and10 mg/kg QW
Sponsors
Shandong New Time Pharmaceutical Co., LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLTs | Up to 21 days | Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period |
| Maximum Tolerated Dose (MTD) | Up to 21 days | Maximum Tolerated Dose |
| RP2D | Up to 21 days | PR2D will be determined by the sponsor and investigator based on the comprehensive data obtained on drug safety and tolerability, PK, preliminary anti-tumor efficacy, etc. |
Countries
China
Contacts
Primary ContactShaohong Yin
Outcome results
None listed