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 National and nearby locations
Children's National Hospital
Washington D.C., District of Columbia 20010
Washington D.C., District of Columbia 20010
More Details
- NCT ID
- NCT06514794
- 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.