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)

May 9, 2026 updated by: Wugen, Inc.

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)

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

125

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3000
        • Recruiting
        • Peter Mac Callum Cancer Institute
        • Contact:
        • Contact:
          • PCCTU HaemA
        • Principal Investigator:
          • Ashish Bajel, M.D.
      • Melbourne, Victoria, Australia, 3000
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Ibrahim Aldoss, MD
        • Contact:
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Principal Investigator:
          • Deepa Bhojwani, MD
        • Contact:
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
        • Principal Investigator:
          • Alireza Eghtedar, M.D.
    • Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • H. Lee Moffitt Cancer Center and Research Institute Hospital
        • Contact:
        • Principal Investigator:
          • Rawan Faramand, M.D.
    • Missouri
      • St Louis, Missouri, United States, 63108
        • Recruiting
        • Washington University Saint Louis
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45229
      • Cincinnati, Ohio, United States, 45226
        • Recruiting
        • Oncology Hematology Care
        • Principal Investigator:
          • Ahmed Galal, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19390
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy
        • Contact:
        • Principal Investigator:
          • Stephen Strickland, M.D.
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • MD Anderson Cancer Center
        • Principal Investigator:
          • Elias Jabbour, M.D.
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Sarah Cannon Transplant and Cellular Therapy Methodist Hospital
        • Principal Investigator:
          • Nosha Farhadfar, M.D.
        • Contact:
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Sarah Cannon, Virginia Oncology Associates
        • Contact:
        • Principal Investigator:
          • Gary L. Simmons, D.O.
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Seattle Children's Hospital
        • Principal Investigator:
          • Adam Lamble, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WU-CART-007

A CD7-directed chimeric antigen receptor (CAR) T-cell product.

Lymphodepletion
Biological: WU-CART-007
A single IV infusion of WU-CART-007

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 months
MRD Pos Cohort - Response Rate
Time Frame: 24 months
Defined as the efficacy of WU-CART-007 to induce complete MRD negative response
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 24 months
Time from study drug administration (Day 1) to death on study
24 months
Objective Response Rate
Time Frame: 24 months
ORR is defined as proportion of patients that achieve CR + CRi, and partial response (PR) in patients with EMD only (R/R Cohort)
24 months
MRD Response Rate (R/R Cohort)
Time Frame: 24 months
Defined as the efficacy of WU-CART-007 to induce complete MRD response as determined by central flow-based MRD assay (R/R Cohort)
24 months
Duration of Response
Time Frame: 24 months
Time of response to the time of disease relapse and/or change in MRD status
24 months
Hematopoietic Stem Cell Transplant (HSCT) rate
Time Frame: 24 months
Rate of successful HSCT through study treatment
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wugen, Inc.

Investigators

  • Study Director: Cherry Thomas, MD, Wugen, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2028

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 9, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WUC007-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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