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It is a multi-center, prospective, open-label, two-stage optimized design, single-arm, phase II clinical study to evaluate the efficacy and safety of F520 for the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) or Secondary Central Nervous System Lymphoma (SCNSL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F520 | Drug | 3mg/kg every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) by Independent Review Committee (IRC) Independent Review Committee (IRC). | Response assessment will be performed according to modified IPCG response. criteria on contrastenhanced cranial MRI-scans. | Approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) based on the investigator assessment. | Response assessment will be performed according to modified IPCG response. | Approximately 24 months |
| Progression-free survival (PFS) |
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Inclusion Criteria:
Male or female of 18 Years and older;
Pathologically confirmed PCNSL or SCNSL of primary testicular diffuse large B-cell lymphoma (PT-DLBCL) who failed or did not respond to at least 1 line of systemic therapy; Recurrence and refractory should meet the following definitions:
Measurable disease requirements on scans: subjects should have at least one measurable extranodal brain lesion more than 10×10mm;
Eastern Cooperative Oncology Group (ECOG) performance status of 0~2;
Agree to provide archived tumor tissue specimens or fresh tissue specimens;
Life expectancy ≥ 3 months;
Adequate laboratory parameters during the screening period as evidenced by the following(No blood components and cell growth factors are allowed within 14 days prior to screening):
routine blood tests: Absolute neutrophil count ≥1.5×109/L ;Platelets ≥100×109/L;Hemoglobin ≥ 9.0 g/dL; Liver function:Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), ALT and AST ≤2.5ULN; for subjects with liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5×ULN, Total bilirubin (TBIL) ≤3×upper limit of normal (ULN); Renal function CCr≤1.5×ULN,Creatinine clearance≥50 mL/min; Thyroid function indicators: thyroid-stimulating hormone (TSH) and free thyroxine (FT3/FT4) are within the normal range or no clinical significant;
International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal;
Understand study procedures and contents, and voluntarily sign the written informed consent form.
Exclusion Criteria:
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F520
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Based on IRC and the investigator assessments.
| Approximately 24 months |
| Duration of response (DOR) | Based on IRC and the investigator assessments. | Approximately 24 months |
| Overall survival (OS) | Approximately 24 months |
| Safety of F520 | AE/SAE will be assessed by CTCAE v5.0 | Approximately 24 months |