WUCART: This phase I/II study is evaluating the safety, recommended dose level, and effectiveness of a new treatment (WU-CART-007) in people with relapsed or refractory T-cell acute lymphoblastic leukaemia or lymphoblastic lymphomaA Phase 1/2 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of Anti-CD7 Allogeneic CAR-T Cells (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

Inclusion

Specific inclusion criteria apply to each disease subtype. In general, all patients will have:

• Evidence of relapsed or refractory T-ALL or T-LBL, as defined by World Health Organization (WHO) classification with bone marrow with ≥ 5% lymphoblasts by morphologic assessment or evidence of extramedullary disease at screening.

• Relapsed or refractory disease defined as at least one of the following criteria:

  1. Primary refractory: failure to achieve CR after induction chemotherapy, per investigator.
  2. Early Relapse: relapsed disease within 12 months of initial diagnosis.
  3. Late Relapse (relapsed refractory disease): relapsed disease after 12 months of initial diagnosis AND failure of re-induction therapy after disease recurrence.
  4. Relapsed or refractory disease after allogeneic transplant, and meet the following criteria:

  i. There must be histological confirmation of relapse after HSCT of T-ALL or T-LBL.

ii. Undergone allogeneic HSCT > 90 days prior to enrollment from a match related or unrelated donor, cord blood donor, haplo-identical, or autologous stem cells.

iii. Off all immunosuppressive medications for a minimum of 2 weeks with the exception of physiologic doses of corticosteroids.

iv. No prior history of Grade 2 or greater (per Cairo-Bishop) veno-occlusive disease (VOD)/sinusoidal obstruction syndrome, or active graft versus host disease (GvHD) (see exclusion criteria below for exceptions).

• Adequate renal, hepatic, respiratory, and cardiovascular function, as defined in the body of the protocol.
• Life expectancy >12 weeks
• Age: Lower age limit of 12 years. Adolescent ages 12-17 will be eligible for enrollment beginning at Dose Level 3 of the Dose Escalation phase, after review of safety, efficacy and cellular PK data and after consultation with the appropriate regulatory agencies.
• ECOG/Karnofsky performance status 0 or 1 at screening (Adults age >16) or Lansky Performance Status 60 and above (adolescents ≤ 16),
• Ability to understand the nature of this study, comply with protocol requirements, and give written informed consent. For minors, legal guardian willingness to give written informed consent with patient assent, where appropriate.
• Willing to participate in WUC-007-02 for long-term follow up.