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The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | Three escalating single-dose groups of chimeric anti-CD20 monoclonal antibody(SCT400) : 250 mg/m2 , 375 mg/m2,500 mg/m2, once a week for 4 doses; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chimeric anti-CD20 monoclonal antibody | Biological |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with infusion-related reaction and with drug-related adverse events. | up to 27 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the plasma concentration versus time curve (AUC) of SCT400 | prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to disease progression | up to 27 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuan kai Shi, PhD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing, China | Principal Investigator |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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