A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma (T-RRex)
Part of paid clinical trials in Duarte, California.
- Sponsor
- Wugen, Inc.
- Study ID
- NCT06514794
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Lymphoblastic Lymphoma
- T-cell Acute Lymphoblastic Leukemia
Eligibility Criteria
- Sex
- ALL
- Age
- 1 Year - N/A
- Healthy Volunteers
- Not accepted
Interventions
- WU-CART-007 — BIOLOGICALA single IV infusion of WU-CART-007
Study Details
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
Key Dates
- Start date
- Jan 31, 2025
- Status verified
- Dec 2025
- Primary completion
- Dec 30, 2026
- Completion
- Dec 30, 2028
Study Design
- Enrollment
- 125 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: WU-CART-007A CD7-directed chimeric antigen receptor (CAR) T-cell product. Lymphodepletion
Primary Outcome Measure
R/R Cohort - Composite Complete Response Rate [ Time Frame: 24 months ]
Central Contacts
- Wugen Clinical Trials314-501-1968
Locations (13)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | Ibrahim Aldoss, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | Deepa Bhojwani, MD (PRINCIPAL_INVESTIGATOR) |
| Colorado Blood Cancer Institute | Denver | Colorado | 80218 | Alireza Eghtedar, M.D. (PRINCIPAL_INVESTIGATOR) |
| H. Lee Moffitt Cancer Center and Research Institute Hospital | Tampa | Florida | 33612 | Garrett Welch Rawan Faramand, M.D. (PRINCIPAL_INVESTIGATOR) |
| Washington University Saint Louis | St Louis | Missouri | 63108 | Katie Stricker |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Jeremy Rubinstein, MD |
| Oncology Hematology Care | Cincinnati | Ohio | 45226 | Ahmed Galal, MD (PRINCIPAL_INVESTIGATOR) |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19390 | Brooke Leibfreid |
| TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy | Nashville | Tennessee | 37203 | Stephen Strickland, M.D. (PRINCIPAL_INVESTIGATOR) |
| MD Anderson Cancer Center | Houston | Texas | 77030 | Elias Jabbour, M.D. (PRINCIPAL_INVESTIGATOR) |
| Sarah Cannon Transplant and Cellular Therapy Methodist Hospital | San Antonio | Texas | 78229 | Nosha Farhadfar, M.D. (PRINCIPAL_INVESTIGATOR) |
| Sarah Cannon, Virginia Oncology Associates | Norfolk | Virginia | 23502 | Gary L. Simmons, D.O. (PRINCIPAL_INVESTIGATOR) |
| Seattle Children's Hospital | Seattle | Washington | 98105 | Adam Lamble, M.D. (PRINCIPAL_INVESTIGATOR) |
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