RecruitingPhase 2NCT06514794

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)

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)


Sponsor

Wugen, Inc.

Enrollment

125 participants

Start Date

Jan 31, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 1 Year

Plain Language Summary

Simplified for easier understanding

This phase 2 study is testing WU-CART-007, an off-the-shelf (donor-derived) CAR-T cell therapy that targets the CD7 protein, in people with T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) that has relapsed, is not responding to treatment, or still has measurable disease after therapy. **You may be eligible if...** - You have a confirmed diagnosis of T-ALL or T-LBL per WHO classification - Your disease has relapsed, is refractory to prior treatment, or shows measurable residual disease (MRD) - You are at least 1 year old - Your physical performance score is adequate (ECOG 0-1, or Karnofsky 70+) - You have adequate organ function **You may NOT be eligible if...** - You have previously received any anti-CD7 therapy - You have severe hemolytic anemia - You have moderate to severe graft-versus-host disease (GvHD) requiring systemic treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALWU-CART-007

A single IV infusion of WU-CART-007


Locations(12)

City of Hope

Duarte, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

H. Lee Moffitt Cancer Center and Research Institute Hospital

Tampa, Florida, United States

Washington University Saint Louis

St Louis, Missouri, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Sarah Cannon Transplant and Cellular Therapy Methodist Hospital

San Antonio, Texas, United States

Sarah Cannon, Virginia Oncology Associates

Norfolk, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

Peter Mac Callum Cancer Institute

Melbourne, Victoria, Australia

Royal Children's Melbourne

Melbourne, Victoria, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06514794


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