Clinical trial NCT05293028: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsed/Refractory Lymphoma
Lead sponsor: Shandong New Time Pharmaceutical Co., LTD
Sponsor class: INDUSTRY
First posted: 2022-03-23
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: DLTs
timeFrame: Up to 21 days
measure: Maximum Tolerated Dose (MTD)
timeFrame: Up to 21 days
measure: RP2D
timeFrame: Up to 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
References: