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)
Purpose
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
Conditions
- T-cell Acute Lymphoblastic Leukemia
- Lymphoblastic Lymphoma
Eligibility
- Eligible Ages
- Over 1 Year
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive - Age: Lower age limit of ≥ 6 months; adequate organ function - Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening.
Exclusion Criteria
- Prior treatment with any anti-CD7 therapy. - Patients with decompensated hemolytic anemia. - Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression. Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- 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.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental WU-CART-007 |
A CD7-directed chimeric antigen receptor (CAR) T-cell product. Lymphodepletion |
|
Recruiting Locations
Children's Hospital Los Angeles
Los Angeles, California 90027
Los Angeles, California 90027
Colorado Blood Cancer Institute
Denver, Colorado 80218
Denver, Colorado 80218
Children's National Hospital
Washington D.C., District of Columbia 20010
Washington D.C., District of Columbia 20010
H. Lee Moffitt Cancer Center and Research Institute Hospital
Tampa, Florida 33612
Tampa, Florida 33612
Children's Hospital of Atlanta
Atlanta, Georgia 30329
Atlanta, Georgia 30329
Washington University Saint Louis
St Louis, Missouri 63108
St Louis, Missouri 63108
Oncology Hematology Care
Cincinnati, Ohio 45226
Cincinnati, Ohio 45226
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19390
Philadelphia, Pennsylvania 19390
TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy
Nashville, Tennessee 37203
Nashville, Tennessee 37203
MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
Sarah Cannon Transplant and Cellular Therapy Methodist Hospital
San Antonio, Texas 78229
San Antonio, Texas 78229
Sarah Cannon, Virginia Oncology Associates
Norfolk, Virginia 23502
Norfolk, Virginia 23502
Seattle Children's Hospital
Seattle, Washington 98105
Seattle, Washington 98105
More Details
- Status
- Recruiting
- Sponsor
- Allotera Therapeutics
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.