Phase 2 Study of WU-CART-007, a New CAR-T Cell Therapy for T-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

Inclusion Criteria

• Have T-Cell Acute Lymphoblastic Leukemia (T-ALL) or Lymphoblastic Lymphoma (LBL) that has come back or not responded to treatment, or have minimal residual disease (MRD) after treatment.
• For relapsed or refractory patients: have at least 5% cancer cells in the bone marrow or evidence of cancer outside the bone marrow.
• For MRD patients: have less than 5% but at least 0.01% cancer cells in the bone marrow.
• Have good liver, kidney, lung, and heart function as determined by specific medical tests.
• Be at least 1 year old.
• Be in good overall health with a performance status score indicating full activity or some restriction in strenuous activities.
• Understand the study and agree to participate, or have a legal guardian provide consent if underage.
• Agree to participate in long-term follow-up.

Exclusion Criteria

• Have received any previous anti-CD7 therapy.
• Have unresolved side effects from previous cancer treatments, except for mild nausea or hair loss.
• Have allergies to specific chemotherapy drugs used in the study.
• Have certain medical conditions like urinary problems, severe anemia, or active infections like hepatitis B, hepatitis C, or HIV.
• Have serious medical conditions that would prevent receiving the study treatment.
• Have active or recent other cancers, or active central nervous system leukemia.
• Be pregnant or breastfeeding.
• Have rapidly progressing disease that could increase the risk of side effects.
• Require medications or treatments not allowed in the study, such as steroids or other cancer drugs.