SummaryThis study consists of two phases. In Phase 1 (Dose Escalation), up to 24 participants will be treated with 2 dose of WU-CART-007, in up to 4 dose levels, until the maximum tolerated dose (MTD) or maximum administered dose (MAD) is determined. Once the recommended phase 2 dose (RP2D) is defined, the Phase 2 portion (Cohort Expansion) will enrol expansion cohorts. WU-CART-007 will be administered via single intravenous (IV) infusion on Day 1 after Lymphodepletion (LD) Therapy. Cyclophosphamide 500mg/m2/day x 3 (days -5 to -3) Fludarabine 30mg/m2/day x 3 (days -5 to -3).
This trial is treating patients with relapsed or refractory T-cell acute lymphoblastic leukaemia or lymphoblastic lymphoma.
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A 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)