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The purpose of this study is to verify the safety and the efficacy of TBI-1301 for NY-ESO-1 expressing synovial sarcoma when administered following cyclophosphamide/fludarabine pre-treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Split dose of 5x10^9 TBI-1301 | Experimental | Split dose of 5x10^9 TBI-1301 will be administered intravenously for 2 days following pre-treatment for 2 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TBI-1301 | Biological | Split dose of TBI-1301 is administered intravenously for 2 days following cyclophosphamide/fludarabine pre-treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate | Evaluate response rate by measuring response using RECIST v1.1 | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka International Cancer Institute | Recruiting | Osaka | Osaka | 541-8567 | Japan |
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| ID | Term |
|---|---|
| D013584 | Sarcoma, Synovial |
| ID | Term |
|---|---|
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Cyclophosphamide | Drug | Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301. |
|
| Fludarabine | Drug | Fludarabine (30mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301. |
|
| Kyusyu University Hospital | Recruiting | Fukuoka | Japan |
|
| D012509 | Sarcoma |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |