A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

Last updated: September 24, 2025
Sponsor: Wugen, Inc.
Overall Status: Completed

Phase

1

Condition

Lymphoma

Leukemia

Lymphocytic Leukemia, Acute

Treatment

WU-CART-007

Clinical Study ID

NCT04984356
WU-CART-007 1001
Wugen, Inc. is the sponsor.
R35CA210084
  • Ages > 12
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, recommended dose, and preliminary anti-tumor activity of WU-CART-007 in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL).

Eligibility Criteria

Inclusion

Key Eligibility Criteria:

  • Diagnosed relapsed or refractory T-ALL or T-LBL, as defined by World Health Organization (WHO) classification

  • Adequate renal, hepatic, respiratory, and cardiovascular function

  • Life expectancy >12 weeks

  • ECOG/Karnofsky performance status 0 or 1 at screening (Adults age >16) or Lansky Performance Status 60 and above (adolescents ≤ 16),

Study Design

Total Participants: 28
Treatment Group(s): 1
Primary Treatment: WU-CART-007
Phase: 1
Study Start date:
January 14, 2022
Estimated Completion Date:
August 08, 2024

Study Description

This is a first-in-human, multicenter, Phase 1, single-arm study in patients with R/R T-ALL/T-LBL who have exhausted other treatment options. The study evaluates dose escalation and dose expansion.

Connect with a study center

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne 2158177, Victoria 2145234
    Australia

    Site Not Available

  • Hospital Saint- Louis

    Paris,
    France

    Site Not Available

  • University Hospital Robert Debre

    Paris,
    France

    Site Not Available

  • Hospital Saint- Louis

    Paris 2988507,
    France

    Site Not Available

  • University Hospital Robert Debre

    Paris 2988507,
    France

    Site Not Available

  • Erasmus MC

    Rotterdam,
    Netherlands

    Site Not Available

  • Erasmus MC

    Rotterdam 2747891,
    Netherlands

    Site Not Available

  • Prinses Maxima Centrum

    Utrecht,
    Netherlands

    Site Not Available

  • Prinses Maxima Centrum

    Utrecht 2745912,
    Netherlands

    Site Not Available

  • City of Hope

    Duarte, California 91010
    United States

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles, California 90027
    United States

    Site Not Available

  • City of Hope

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • Children's Hospital Los Angeles

    Los Angeles 5368361, California 5332921 90027
    United States

    Site Not Available

  • Moffit Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Moffitt Cancer Center

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Washington University

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • University of Nebraska

    Omaha, Nebraska 68198
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19104
    United States

    Site Not Available

  • Vanderbilt University

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Vanderbilt University

    Nashville 4644585, Tennessee 4662168 37212
    United States

    Site Not Available

  • University of Wisconsin

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University of Wisconsin

    Madison 5261457, Wisconsin 5279468 53792
    United States

    Site Not Available

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