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NCT06514794PHASE2Recruiting

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)

Wugen, Inc.

Start Date

1/31/2025

Completion Date

12/30/2028

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

Detailed 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.

Eligibility Criteria

Age Range: 1 years to No maximum

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.

Interventions

BIOLOGICAL

WU-CART-007

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Conditions

T-cell Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma

Locations

City of Hope

Duarte, California 91010

United States

Children's Hospital Los Angeles

Los Angeles, California 90027

United States

Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

H. Lee Moffitt Cancer Center and Research Institute Hospital

Tampa, Florida 33612

United States

Washington University Saint Louis

St Louis, Missouri 63108

United States

Oncology Hematology Care

Cincinnati, Ohio 45226

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19390

United States

TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy

Nashville, Tennessee 37203

United States

MD Anderson Cancer Center

Houston, Texas 77030

United States

Sarah Cannon Transplant and Cellular Therapy Methodist Hospital

San Antonio, Texas 78229

United States

Sarah Cannon, Virginia Oncology Associates

Norfolk, Virginia 23502

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States

Peter Mac Callum Cancer Institute

Melbourne, Victoria 3000

Australia

Royal Children's Melbourne

Melbourne, Victoria 3000

Australia