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The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response
This is a Phase 2, single-arm, multi-center, open label study in patients with R/R T-ALL/LBL and T-ALL/LBL in remission but remaining MRD positive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WU-CART-007 | Experimental | A CD7-directed chimeric antigen receptor (CAR) T-cell product. Lymphodepletion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WU-CART-007 | Biological | A single IV infusion of WU-CART-007 |
|
| Measure | Description | Time Frame |
|---|---|---|
| R/R Cohort - Composite Complete Response Rate | CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi) | 24 months |
| MRD Pos Cohort - Response Rate | Defined as the efficacy of WU-CART-007 to induce complete MRD negative response | 24 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wugen Clinical Trials | Contact | 314-501-1968 | clinicaltrials@wugen.com |
| Name | Affiliation | Role |
|---|---|---|
| Cherry Thomas, MD | Wugen, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Recruiting | Duarte | California | 91010 | United States |
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The study is divided into 2 cohorts:
Relapsed/Refractory (R/R) Cohort will evaluate patients with relapsed or refractory disease
Minimal Residual Disease (MRD) Positive Cohort will evaluate patients in complete remission with MRD positive disease.
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| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
|
| Colorado Blood Cancer Institute | Recruiting | Denver | Colorado | 80218 | United States |
|
| H. Lee Moffitt Cancer Center and Research Institute Hospital | Recruiting | Tampa | Florida | 33612 | United States |
|
| Washington University Saint Louis | Recruiting | St Louis | Missouri | 63108 | United States |
|
| Oncology Hematology Care | Recruiting | Cincinnati | Ohio | 45226 | United States |
|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
|
| Children's Hospital of Philadelphia | Recruiting | Philadelphia | Pennsylvania | 19390 | United States |
|
| TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| Sarah Cannon Transplant and Cellular Therapy Methodist Hospital | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Sarah Cannon, Virginia Oncology Associates | Recruiting | Norfolk | Virginia | 23502 | United States |
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| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
|
| Peter Mac Callum Cancer Institute | Recruiting | Melbourne | Victoria | 3000 | Australia |
|
| Royal Children's Melbourne | Recruiting | Melbourne | Victoria | 3000 | Australia |
|
| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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