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

Last updated: April 11, 2025
Sponsor: Wugen, Inc.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Leukemia

Lymphoproliferative Disorders

Lymphocytic Leukemia, Acute

Treatment

WU-CART-007

Clinical Study ID

NCT06514794
WUC007-03
  • Ages > 1
  • All Genders

Study Summary

The main purpose of this study is to evaluate the Composite Complete Remission Rate (CRc) of WU-CART-007 in Relapsed/Refractory (R/R) T-Cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL) patients and to evaluate the efficacy of WU-CART-007 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,defined as:

  • Relapsed or Refractory Cohort: disease defined by bone marrow with ≥5%lymphoblasts by morphologic assessment or flow cytometry or evidence ofextramedullary disease (EMD).

  • Minimal Residual Disease (MRD) Cohort: evidence of MRD, defined as < 5% blastsin bone marrow but ≥ 0.01% blasts determined by central laboratory flowcytometry assay

  • Adequate Organ Function

  • Age: Lower age limit of ≥ 1 year.

  • Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/60 andabove at Screening (Adults age > 16) or Lansky Performance Status 60 and above (pediatrics/ adolescents age ≤16).

Exclusion

Key Exclusion Criteria:

  • Treatment with any prior anti-CD7 therapy.

  • Patients with decompensated hemolytic anemia.

  • Presence of Grade 2 to 4 acute or extensive chronic GvHD requiring systemicimmunosuppression (e.g. steroids). Grade 1 GvHD not requiring immunosuppression orGrade 2 skin GvHD if 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-agent study in patients with R/R T-ALL/LBL and T-ALL/LBL in remission but remaining MRD positive.

The study is divided into 2 disease Cohorts. The Relapsed/Refractory (R/R) Cohort will evaluate patients with relapsed or refractory disease, defined as ≥5% blast in the BM and/or extramedullary disease (EMD) only. An exploratory MRD positive cohort will evaluate patients in complete remission with MRD positive disease (>0.1 but < 5% blasts in the BM)

Data for each age group will be reviewed by the Data Safety Committee (DSC) following enrollment of 12 patients.

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

  • 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

  • Moffit Cancer Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Washington University Saint Louis

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania 19390
    United States

    Site Not Available

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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