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)

Key Inclusion Criteria:

• Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World HealthOrganization (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 ofextramedullary disease (EMD).

• Minimal Residual Disease (MRD) Cohort: evidence of MRD, defined as < 5% blastsin bone marrow but ≥ 0.01% blasts determined by central laboratory flowcytometry assay

• Adequate Organ Function

• Age: Lower age limit of ≥ 1 year.

• Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 andabove at Screening (Adults age > 16) or Lansky Performance Status 60 and above (pediatrics/ adolescents age ≤16).

Key Exclusion Criteria:

• Treatment with any prior anti-CD7 therapy.

• Patients with decompensated hemolytic anemia.

• Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemicimmunosuppression (e.g. steroids). Grade 1 GvHD not requiring immunosuppression orGrade 2 skin GvHD if treated with topical therapy only are acceptable.