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)
NCT06514794 · Phase 2 · Duarte, California, United States
- Condition
- Leukemia
- Disease stage
- Stage I-IV
- Phase
- Phase 2
- Study type
- BIOLOGICAL
- Intervention
- WU-CART-007
- Age
- 6 Months to
- Gender
- All
- Sponsor
- Allotera Therapeutics
- Research institution
- Allotera Therapeutics
- Facility
- City of Hope
- Research center
- City of Hope
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.
Inclusion criteria
Key * 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. Key
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.
Primary outcomes
R/R Cohort - Composite Complete Response Rate; MRD Pos Cohort - Response Rate