A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy in Patients With Relapsed/Refractory Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma (T-RRex)
Summary
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
Detailed description
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.
Arms & interventions
- BiologicalWU-CART-007
A single IV infusion of WU-CART-007
Outcome measures
Primary
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)
Time frame: 24 months
MRD Pos Cohort - Response Rate
Defined as the efficacy of WU-CART-007 to induce complete MRD negative response
Time frame: 24 months
Eligibility criteria
Study locations (13)
City of Hope
Duarte, California, 91010
Children's Hospital Los Angeles
Los Angeles, California, 90027
Colorado Blood Cancer Institute
Denver, Colorado, 80218
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida, 33612
Washington University Saint Louis
St Louis, Missouri, 63108
Oncology Hematology Care
Cincinnati, Ohio, 45226
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19390
TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy
Nashville, Tennessee, 37203
MD Anderson Cancer Center
Houston, Texas, 77030
Sarah Cannon Transplant and Cellular Therapy Methodist Hospital
San Antonio, Texas, 78229
Sarah Cannon, Virginia Oncology Associates
Norfolk, Virginia, 23502
Seattle Children's Hospital
Seattle, Washington, 98105