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This study is a single arm, non-randomized, open label phase 2 international, multicenter clinical trial to evaluate preliminary efficacy and safety in subjects with relapsed or refractory lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6MW3211 | Experimental | 6MW3211 injection, 45mg/kg, Q2W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6MW3211 | Drug | 6MW3211 injection, 45mg/kg, Q2W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Defined as the percentage of subjects who experience a best response of either CR or PR | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | Defined as the percentage of subjects who experience a best response of CR | 1 Year |
| Duration of response | Time from the date of the first complete response (CR) or partial response (PR) to the earliest date of disease progression or death from any cause |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao, Doctor | Contact | 021-64370045 | zwl_trail@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Saijuan Chen, Doctor | Ruijin Hospital | Principal Investigator |
| Weili Zhao, Doctor | Ruijin Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| 1 Year |
| Time to response | Time from the date of first infusion to the date of confirmed CR or PR | 1 Year |
| Progression free survival | Time from the date of first infusion to the earliest date of documented disease progression per radiological evidence or death from any cause | 1 Year |
| Overall survival | Time from the date of first infusion until the date of death from any cause | 1 Year |
| Incidence of adverse events | Up to 28 days post last dose |
| PK Parameter | Maximum concentration (Cmax) | 1 Year |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |