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A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

A Phase 1 Dose-Escalation and Dose-Expansion Study of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia (T-ALL)/Lymphoblastic Lymphoma (LBL)

NCT04984356•Wugen, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety, recommended dose, and preliminary anti-tumor activity of WU-CART-007 in patients with relapsed or refractory (R/R) T-cell acute lymphoblastic leukemia (T-ALL) or lymphoblastic lymphoma (LBL).

Detailed Description

This is a first-in-human, multicenter, Phase 1, single-arm study in patients with R/R T-ALL/T-LBL who have exhausted other treatment options. The study evaluates dose escalation and dose expansion.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Key Eligibility Criteria:
•Diagnosed relapsed or refractory T-ALL or T-LBL, as defined by World Health Organization (WHO) classification
•Adequate renal, hepatic, respiratory, and cardiovascular function
•Life expectancy \>12 weeks
•ECOG/Karnofsky performance status 0 or 1 at screening (Adults age \>16) or Lansky Performance Status 60 and above (adolescents ≤ 16),

Locations (12)

City of Hope

Duarte, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Washington University

St Louis, Missouri, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Vanderbilt University

Nashville, Tennessee, United States

University of Wisconsin

Madison, Wisconsin, United States

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Hospital Saint- Louis

Paris, France

University Hospital Robert Debre

Paris, France

Key Dates

Start Date

January 14, 2022

Primary Completion Date

August 8, 2024

Completion Date

August 8, 2024

Last Updated

September 30, 2025

Enrollment

ACTUAL participants

Conditions

T-cell Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma

Interventions

WU-CART-007

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase 1 Study of of Anti-CD7 Allogeneic CAR-T Cell Therapy (WU-CART-007) in Patients With Relapsed or Refractory T-ALL/LBL

Inclusion Criteria

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

Venetoclax Basket Trial for High Risk Hematologic Malignancies

Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

Dose-Adjusted EPOCH With or Without Rituximab Plus Ponatinib for the Treatment of Newly-Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia/Lymphoma

Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma