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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 and refractory peripheral T cell lymphoma (PTCL), and to evaluate the immunogenicity of F520.
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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) | To evaluate the efficacy of F520 as defined by objective response rate (evaluated by IRC) in patients with relapsed or refractory PTCL. | Approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | To evaluate the efficacy of F520 as defined by objective response rate (evaluated by investigator) in patients with relapsed or refractory PTCL. | Approximately 24 months |
| Completed response rate (CRR) |
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Inclusion Criteria:
Aged 18 years or older, male or female;
Histologically confirmed relapsed or refractory PTCL patients who had received systemic treatment at least once but had failed to; Relapsed / refractory is defined as follows:
Relapsed: patients who have new lesions at the primary site or other sites after reaching CR in the previous treatment; Refractory: patients who fail to reach PR in 2 cycles or CR in 4 cycles after first-line or above systemic treatment; if the best effect or end cause is PD, the number of cycles is not required;
ECOG score of 0-2;
Life expectancy≥3 months;
Agree to provide archived tumor tissue samples or fresh tissue samples, including enough samples to complete PD-L1 test;
Computed tomography (ct) scans should show the presence of at least one of two vertical orientations; The tumor lesions that could be measured were defined, with the longest diameter of intranode lesion > 1.5cm, the shortest diameter of intranode lesion > 1.0cm and the longest diameter of extranode lesion > 1.0cm;
The functions of important organs meet the following requirements (drugs with any blood component and cell growth factor are not allowed to be used within 14 days before the first administration):
routine blood tests: hemoglobin ≥ 90 g/L, neutrophil ≥ 1.5 ×109/L, platelet ≥ 75×109/L; Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); If there is liver metastasis, TBIL ≤ 3 × ULN, ALT and AST ≤ 5 × ULN; Serum creatinine ≤ 1.5×ULN; Thyroid function indicators: thyroid-stimulating hormone (TSH) are within the normal range or thyroid-stimulating hormone (TSH) are not within the normal range and free thyroxine (FT3/FT4) are within the normal range;
Sign the written informed consent, and be able to follow the visit and related procedures specified in the protocol.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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F520
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To evaluate the efficacy of F520 as defined by completed response rate (evaluated by investigator/IRC) in patients with relapsed or refractory PTCL.
| Approximately 24 months |
| Duration of response (DOR) | To evaluate the duration of response (DOR) of F520 in patients with relapsed or refractory PTCL. | Approximately 24 months |
| Overall survival (OS) | To evaluate the duration from the first administration to death because of any reason in patients with relapsed or refractory PTCL. | Approximately 24 months |
| Progression-free survival (PFS) | To evaluate the efficacy of F520 as defined by progression-free survival, in patients with relapsed or refractory PTCL. | Approximately 24 months |
| Disease control rate (DCR) | To evaluate the efficacy of F520 as defined by disease control rate, in patients with relapsed or refractory PTCL. | Approximately 24 months |
| Time to response (TTR) | To evaluate the efficacy of F520 as defined by time to response in patients with relapsed or refractory PTCL. | Approximately 24 months |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |