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

Eligibility 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, defined as:
• * Relapsed or Refractory Cohort: disease defined by bone marrow with ≥5% lymphoblasts by morphologic assessment or flow cytometry or evidence of extramedullary disease (EMD).
• * Minimal Residual Disease (MRD) Cohort: evidence of MRD, defined as \< 5% blasts in bone marrow but ≥ 0.01% blasts determined by central laboratory flow cytometry assay
• * Adequate Organ Function
• * Age: Lower age limit of ≥ 1 year.
• * Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/60 and above at Screening (Adults age \> 16) or Lansky Performance Status 60 and above (pediatrics/ adolescents age ≤16).
• * Treatment with any prior anti-CD7 therapy.
• * Patients with decompensated hemolytic anemia.
• * Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemic immunosuppression (e.g. steroids). Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.