Study of F527 in Patients With Relapsed or Refractory Lymphoma

Relapsed/Refractory Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05293028
• Other study ID #: NTP-F527-001
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: May 20, 2022
• Est. completion date: May 20, 2024

Study information

• Verified date: March 2022
• Source: Shandong New Time Pharmaceutical Co., LTD
• Contact: Shaohong Yin
• Phone: 86-15265901803
• Email: yinshaohong[@]lunan.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 82
• Est. completion date: May 20, 2024
• Est. primary completion date: November 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 (SIRPa)-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.

Related Conditions & MeSH terms

• Lymphoma
• Relapsed/Refractory Lymphoma

Intervention

Drug:
• F527
0.001?0.01?0.1?0.3?1?3 and10 mg/kg QW

Locations

Country	Name	City	State
China	Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shandong New Time Pharmaceutical Co., LTD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLTs	Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period	Up to 21 days
Primary	Maximum Tolerated Dose (MTD)	Maximum Tolerated Dose	Up to 21 days
Primary	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