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)

NCT ID: NCT06514794

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2028-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

T-cell Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

The study is divided into 2 cohorts:

Relapsed/Refractory (R/R) Cohort will evaluate patients with relapsed or refractory disease

Minimal Residual Disease (MRD) Positive Cohort will evaluate patients in complete remission with MRD positive disease.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

WU-CART-007

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

Lymphodepletion

Group Type EXPERIMENTAL

WU-CART-007

Intervention Type BIOLOGICAL

A single IV infusion of WU-CART-007

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

WU-CART-007

A single IV infusion of WU-CART-007

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 ≥ 1 year; adequate organ function
* Eastern Cooperative Oncology Group (ECOG)/Karnofsky Performance Status 0 or 1/70 and above at Screening.

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.
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wugen, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cherry Thomas, MD

Role: STUDY_DIRECTOR

Wugen, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

City of Hope

Duarte, California, United States

Site Status RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

H. Lee Moffitt Cancer Center and Research Institute Hospital

Tampa, Florida, United States

Site Status RECRUITING

Washington University Saint Louis

St Louis, Missouri, United States

Site Status RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Peter Mac Callum Cancer Institute

Melbourne, Victoria, Australia

Site Status RECRUITING

Royal Children's Melbourne

Melbourne, Victoria, Australia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wugen Clinical Trials

Role: CONTACT

314-501-1968

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Role: primary

Angela Kang

Role: primary

Amber Medina

Role: backup

Katie Stricker

Role: primary

Jeremy Rubinstein, MD

Role: primary

Brooke Leibfreid

Role: primary

Ashish Bajel, M.D.

Role: primary

Seong Lin Khaw, M.D.

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

WUC007-03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CART22 Alone or in Combination With huCART19 for ALL
NCT03620058 ACTIVE_NOT_RECRUITING PHASE1