Study of F527 in Patients With Relapsed or Refractory Lymphoma

Study Overview
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Brief Summary
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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.

Official Title
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Phase I Clinical Study of Safety, Tolerability, Preliminary Efficacy and Pharmacokinetics of F527 in the Treatment of Patients With Relapsed or Refractory Lymphoma

Conditions
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Relapsed/Refractory Lymphoma

Intervention / Treatment
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* Drug: F527


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged ≥18 and ≤80 years old; 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; Subjects must have at least one measurable lesion assessed by the investigator (long diameter of lymph node>15mm, long diameter of extranodal lesion>10mm); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2; Expected survival period ≥ 3 months; 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; Understand the test procedures and content, and sign the informed consent voluntarily. Exclusion Criteria: Special types of lymphoma such as primary/secondary central nervous system lymphoma, etc.; 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.); History of hemolytic anemia or Evans syndrome in the last three months; Positive direct antiglobulin test; Those who have used CD47-targeted drugs or signal-regulated protein alpha (SIRPα)-targeted drugs in the past; 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); 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; 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); 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); Patients who have received any other clinical trial drug treatment within 4 weeks before the first dose; Patients who have received live attenuated vaccine within 4 weeks before the first dose; 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; Patients with a history of mental illness or drug abuse; 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); Patients who are judged by the investigator to be unsuitable for enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug:F527<br>F527 is dose-escalated sequentially by accelerated titration and i3+3 design. | Drug: F527<br>* 0.001、0.01、0.1、0.3、1、3 and10 mg/kg QW<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DLTs | Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period | Up to 21 days | 
| Maximum Tolerated Dose (MTD) | Maximum Tolerated Dose | Up to 21 days | 
| RP2D | 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. | Up to 21 days |