Study of F527 in Patients With Relapsed or Refractory Lymphoma
Primary Purpose
Relapsed/Refractory Lymphoma
Status
Not yet recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
F527
Sponsored by
About this trial
This is an interventional treatment trial for Relapsed/Refractory Lymphoma
Eligibility Criteria
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.
Sites / Locations
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Drug:F527
Arm Description
F527 is dose-escalated sequentially by accelerated titration and i3+3 design.
Outcomes
Primary Outcome Measures
DLTs
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Maximum Tolerated Dose (MTD)
Maximum Tolerated Dose
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05293028
First Posted
March 3, 2022
Last Updated
March 14, 2022
Sponsor
Shandong New Time Pharmaceutical Co., LTD
1. Study Identification
Unique Protocol Identification Number
NCT05293028
Brief Title
Study of F527 in Patients With Relapsed or Refractory Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 20, 2022 (Anticipated)
Primary Completion Date
November 20, 2023 (Anticipated)
Study Completion Date
May 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong New Time Pharmaceutical Co., LTD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed/Refractory Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Drug:F527
Arm Type
Experimental
Arm Description
F527 is dose-escalated sequentially by accelerated titration and i3+3 design.
Intervention Type
Drug
Intervention Name(s)
F527
Intervention Description
0.001、0.01、0.1、0.3、1、3 and10 mg/kg QW
Primary Outcome Measure Information:
Title
DLTs
Description
Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period
Time Frame
Up to 21 days
Title
Maximum Tolerated Dose (MTD)
Description
Maximum Tolerated Dose
Time Frame
Up to 21 days
Title
RP2D
Description
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.
Time Frame
Up to 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaohong Yin
Phone
86-15265901803
Email
yinshaohong@lunan.com.cn
Facility Information:
Facility Name
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weili Zhao
12. IPD Sharing Statement
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Study of F527 in Patients With Relapsed or Refractory Lymphoma
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