Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01343043 | A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1ᶜ²⁵⁹T in HLA-A2+ Patients With Synovial Sarcoma | PHASE1 | COMPLETED | 50 | — | — | Sep 27, 2012 | Jun 18, 2019 | Jun 30, 2021 | 8 | United States |
ORR was calculated as the percentage of participants with a confirmed complete response (CR) or partial response (PR) relative to the total number of participants in the analysis population per response evaluation criteria in solid tumors (RECIST) version (v)1.1 as determined by the local investigators.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 treated with NY-ESO-1 T Cells | EXPERIMENTAL | High NY-ESO-1 expression and the use of cyclophosphamide plus fludarabine as the lymphodepleting chemotherapy. |
| Cohort 2 treated with NY-ESO-1 T Cells | EXPERIMENTAL | Low NY-ESO-1 expression and the use of cyclophosphamide plus fludarabine as the lymphodepleting chemotherapy. |
| Cohort 3 treated with NY-ESO-1 T Cells | EXPERIMENTAL | High NYESO-1 expression and the use of cyclophosphamide only for lymphodepletion rather than fludarabine as the lymphodepleting chemotherapy. |
| Cohort 4 treated with NY-ESO-1 T Cells | EXPERIMENTAL | High NY-ESO-1 expression and the use of reduced dose cyclophosphamide plus fludarabine regimen as the lymphodepleting chemotherapy. |
| Name | Type | Description |
|---|---|---|
| NY-ESO-1(c259)T Cells | DRUG | Lymphodepleting chemotherapy followed by infusion with NY-ESO-1(c259) transduced autologous T cells. Subjects will receive one infusion of NY-ESO-1 genetically engineered T cells on Day 0. |
| Fludarabine | DRUG | Fludarabine will be used as lymphodepleting chemotherapy. |
| Cyclophosphamide | DRUG | Cyclophosphamide will be used as lymphodepleting chemotherapy. |
Inclusion Criteria: * Synovial sarcoma that has been treated with standard chemotherapy containing ifosfamide and/or doxorubicin and remains: unresectable or metastatic or progressive/persistent or recurrent disease * Measurable disease * Patients must have proven positive tumor sample for NY-ESO-1...