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NCT Number: NCT06514794

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)

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

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Key information

Conditions

T-cell Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoblastic Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peter Mac Callum Cancer Institute, Melbourne, Victoria, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Disease Criteria: Evidence of T-ALL or T-LBL, as defined by World Health Organization (WHO) classification, and either relapse/refractory or MRD positive
  • Age: Lower age limit of ≥ 6 months; adequate organ function
  • Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening.

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 systemic immunosuppression. Grade 1 GvHD not requiring immunosuppression or Grade 2 skin GvHD if treated with topical therapy only are acceptable.

Treatment and study plan

WU-CART-007

Biological

A single IV infusion of WU-CART-007

Primary outcomes

  1. R/R Cohort - Composite Complete Response Rate

    Time frame: 24 months

    CRc is defined as proportion of patients that achieve a complete remission (CR) + CR with incomplete hematologic recovery (CRi)

  2. MRD Pos Cohort - Response Rate

    Time frame: 24 months

    Defined as the efficacy of WU-CART-007 to induce complete MRD negative response

Study contacts

Contact information is provided by the study sponsor or research team.

Wugen Clinical Trials

CONTACT

[email protected]

314-501-1968

Sponsors and collaborators

Lead sponsor

Wugen, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jul 23, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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