A Phase 2 Study of WU-CART-007, an Anti-CD7 Allogeneic CAR-T Cell Therapy inT-Cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

• Biological: WU-CART-007

Inclusion Criteria:

• Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapsethe return of disease/refractory or MRD positive, defined as:
  • Relapsed or Refractory Cohort: disease defined by bone marrowsoft, spongy tissue found in bones that makes blood cells with ≥5% lymphoblasts by morphologic assessment or flow cytometry or evidence of extramedullary disease (EMD). Patients must also be characterized by at least one of the following criteria:
    • Primary refractory: failure to achieve remission after bona fide induction attempt which may include consolidation.
    • Early Relapse: relapsed disease within 24 months of initial diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results.
    • Late Relapse (relapsed refractory disease): relapsed disease after 24 months of initial diagnosis AND failure of re- induction therapy after disease recurrenceto occur or happen again.
    • Relapsed or refractory disease after allogeneic transplant,
  • 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, and characterized by at least one of the following criteria:
    • Failure to reach MRD negative status following induction and consolidation in frontline therapy or reinduction for relapse.
    • MRD positive disease following allogeneic HSCT.
• Adequate Organ Function as defined as:
  • Hepatic and renal function:
    • Hepatic transaminase (both alanine aminotransferase and aspartate aminotransferase) levels ≤5 times the institutional upper limit of normal (ULN),
    • Total bilirubin level ≤1.5 times the ULN (unless the patient has a history of Gilbert’s Syndrome, in which case, total bilirubin must be ≤2.5 times the ULN),
    • Serum creatinine level ≤1.5 times the ULN or a calculated or measured creatinine clearance of ≥50 ml/min.
  • Respiratory function: Must have a minimum level of pulmonary reserve defined as pulse oxygenation >91% on room air.
  • Cardiovascular function: left ventricular ejection fraction ≥45% for adults or shortening fraction ≥ 28% for pediatric patients confirmed by echocardiograma type of ultrasound that uses sound waves to create detailed images of the heart to assess heart structure, function and blood flow or MUGA within 28 days of Screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.
• Age: Lower age limit of ≥ 1 year.
• Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer 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).
• Ability to understand the nature of this study, comply with protocol requirements, and give written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment.. For minors, legal guardian willingness to give written informed consent with patient assent, where appropriate.
• Willing to participate in WUC007-02 for long term follow-up.