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| ID | Type | Description | Link |
|---|---|---|---|
| R35CA210084 | U.S. NIH Grant/Contract | View source | |
| Wugen, Inc. is the sponsor. | Other Identifier | Wugen, Inc. is the sponsor. |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to evaluate the safety, recommended dose, and preliminary anti-tumor activity of WU-CART-007 in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL).
This is a first-in-human, multicenter, Phase 1, single-arm study in patients with R/R T-ALL/T-LBL who have exhausted other treatment options. The study evaluates dose escalation and dose expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WU-CART-007 | Experimental | A CD7-directed chimeric antigen receptor (CAR) T-cell product. A single IV infusion of WU-CART-007 Cells on Day 1 after lymphodepletion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WU-CART-007 | Biological | A single IV infusion of WU-CART-007 Cells on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events of WU-CART-007 as assessed by CTCAE v5 | Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until end of study visit | 24 months |
| Maximum Tolerated Dose (MTD) | Maximum tolerated or administered dose of WU-CART-007 | up to 28 days from first dose |
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Key Eligibility Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cherry Thomas, MD | Wugen, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States | ||
| Children's Hospital Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40445850 | Derived | Ghobadi A, Aldoss I, Maude SL, Bhojwani D, Wayne AS, Bajel A, Dholaria B, Faramand R, Mattison RJ, Rijneveld A, Zwaan CM, Calkoen F, Baruchel A, Boissel N, Rettig M, Wood B, Jacobs K, Christ S, Irons H, Capoccia B, Masters D, Gonzalez J, Wu T, Rosario MD, Hamil A, Bakkacha O, Muth J, Ramsey B, McNulty E, Baughman J, Cooper ML, Davidson-Moncada J, DiPersio JF. Phase 1/2 trial of anti-CD7 allogeneic WU-CART-007 for patients with relapsed/refractory T-cell malignancies. Blood. 2025 Sep 4;146(10):1163-1173. doi: 10.1182/blood.2025028387. | |
| 39149468 |
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There are two parts to this study, Dose Escalation, and Expansion.
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| Los Angeles |
| California |
| 90027 |
| United States |
| Moffitt Cancer Center | Tampa | Florida | 33612 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| Vanderbilt University | Nashville | Tennessee | 37212 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | Australia |
| Hospital Saint- Louis | Paris | France |
| University Hospital Robert Debre | Paris | France |
| Erasmus MC | Rotterdam | Netherlands |
| Prinses Maxima Centrum | Utrecht | Netherlands |
| Derived |
| Ghobadi A, Aldoss I, Maude S, Bhojwani D, Wayne A, Bajel A, Dholaria B, Faramand R, Mattison R, Rijneveld A, Zwaan C, Calkoen F, Baruchel A, Boissel N, Rettig M, Wood B, Jacobs K, Christ S, Irons H, Capoccia B, Gonzalez J, Wu T, Del Rosario M, Hamil A, Bakkacha O, Muth J, Ramsey B, McNulty E, Cooper M, Baughman J, Davidson-Moncada J, DiPersio J. Anti-CD7 allogeneic WU-CART-007 in patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma: a phase 1/2 trial. Res Sq [Preprint]. 2024 Aug 5:rs.3.rs-4676375. doi: 10.21203/rs.3.rs-4676375/v1. |
| 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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