Study of F527 in Patients With Relapsed or Refractory Lymphoma

NCT ID: NCT05293028

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2024-05-20

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.

Conditions

Relapsed/Refractory Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug:F527

F527 is dose-escalated sequentially by accelerated titration and i3+3 design.

Group Type: EXPERIMENTAL

F527

Intervention Type: DRUG

0.001、0.01、0.1、0.3、1、3 and10 mg/kg QW

Interventions

F527

0.001、0.01、0.1、0.3、1、3 and10 mg/kg QW

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong New Time Pharmaceutical Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Shaohong Yin

Role: CONTACT

yinshaohong@lunan.com.cn

86-15265901803

Facility Contacts

Weili Zhao

Role: primary

Other Identifiers

NTP-F527-001

Identifier Type: -

Identifier Source: org_study_id