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A Phase 1 Dose-Escalation and Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

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Trial Profile

A Phase 1 Dose-Escalation and Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 06 Feb 2026

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At a glance

  • Drugs WU-CART-007 (Primary) ; Cyclophosphamide; Fludarabine
  • Indications Precursor cell lymphoblastic leukaemia-lymphoma; Precursor T-cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Sponsors WUGEN

Most Recent Events

  • 21 Jan 2026 According to a WUGEN media release, based on results of this trial the U.S. Food and Drug Administration (FDA) has given Breakthrough Therapy Designation to WU-CART-007 for the treatment of T cell malignancies.
  • 05 Dec 2025 Results presented in the WUGEN Media Release.
  • 05 Dec 2025 According to a WUGEN media release, the company will present Phase 1/2 correlative data and long-term follow-up update for its investigational cell therapy (WU-CART-007) at the American Society of Hematology (ASH) Annual Meeting & Exposition, Dec. 6-9 in Orlando.

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