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

Last updated: January 2, 2026
Sponsor: Wugen, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Leukemia

Lymphocytic Leukemia, Acute

Lymphoma

Treatment

WU-CART-007

Clinical Study ID

NCT06514794
WUC007-03
  • Ages > 1
  • All Genders

Study Summary

The T-RRex study evaluates the efficacy of WU-CART-007 for patients with Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) and to WU-CART-007 as a therapy to induce complete Minimum Residual Disease (MRD) negative response

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World HealthOrganization (WHO) classification, and either relapse/refractory or MRD positive

  • Age: Lower age limit of ≥ 1 year; adequate organ function

  • Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 andabove at Screening.

Exclusion

Key Exclusion Criteria:

  • Prior treatment with any anti-CD7 therapy.

  • Patients with decompensated hemolytic anemia.

  • Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemicimmunosuppression. Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHDif treated with topical therapy only are acceptable.

Study Design

Total Participants: 125
Treatment Group(s): 1
Primary Treatment: WU-CART-007
Phase: 2
Study Start date:
January 31, 2025
Estimated Completion Date:
December 30, 2028

Study Description

This is a Phase 2, single-arm, multi-center, open label study in patients with R/R T-ALL/LBL and T-ALL/LBL in remission but remaining MRD positive.

Connect with a study center

  • Peter Mac Callum Cancer Institute

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Royal Children's Melbourne

    Melbourne, Victoria 3000
    Australia

    Site Not Available

  • Peter Mac Callum Cancer Institute

    Melbourne 2158177, Victoria 2145234 3000
    Australia

    Active - Recruiting

  • Royal Children's Melbourne

    Melbourne 2158177, Victoria 2145234 3000
    Australia

    Active - Recruiting

  • 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

    Active - Recruiting

  • Children's Hospital Los Angeles

    Los Angeles 5368361, California 5332921 90027
    United States

    Active - Recruiting

  • Moffit Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center and Research Institute Hospital

    Tampa 4174757, Florida 4155751 33612
    United States

    Active - Recruiting

  • Washington University Saint Louis

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Washington University Saint Louis

    St Louis 4407066, Missouri 4398678 63108
    United States

    Active - Recruiting

  • Cincinnati Children's Hospital Medical Center

    Cincinnati 4508722, Ohio 5165418 45229
    United States

    Active - Recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19390
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia 4560349, Pennsylvania 6254927 19390
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Seattle Children's Hospital

    Seattle 5809844, Washington 5815135 98105
    United States

    Active - Recruiting

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