NCT06514794

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P75+ for phase_2

Timeline
33mo left

Started Jan 2025

Typical duration for phase_2

Geographic Reach
2 countries

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jan 2025Dec 2028

First Submitted

Initial submission to the registry

July 17, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 23, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

January 31, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2028

Last Updated

April 22, 2026

Status Verified

December 1, 2025

Enrollment Period

1.9 years

First QC Date

July 17, 2024

Last Update Submit

April 21, 2026

Conditions

T-cell Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma

Keywords

CAR-T Therapy

Outcome Measures

Primary Outcomes (2)

  • R/R Cohort - Composite Complete Response Rate

    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

    Defined as the efficacy of WU-CART-007 to induce complete MRD negative response

    24 months

Study Arms (1)

WU-CART-007

EXPERIMENTAL

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

Biological: WU-CART-007

Interventions

WU-CART-007BIOLOGICAL

A single IV infusion of WU-CART-007

WU-CART-007

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

City of Hope

Duarte, California, 91010, United States

RECRUITING

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

H. Lee Moffitt Cancer Center and Research Institute Hospital

Tampa, Florida, 33612, United States

RECRUITING

Washington University Saint Louis

St Louis, Missouri, 63108, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19390, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Sarah Cannon Transplant and Cellular Therapy Methodist Hospital

San Antonio, Texas, 78229, United States

RECRUITING

Sarah Cannon, Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Peter Mac Callum Cancer Institute

Melbourne, Victoria, 3000, Australia

RECRUITING

Royal Children's Melbourne

Melbourne, Victoria, 3000, Australia

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-LymphomaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Cherry Thomas, MD

    Wugen, Inc.

    STUDY DIRECTOR

Central Study Contacts

Wugen Clinical Trials

CONTACT

314-501-1968clinicaltrials@wugen.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 23, 2024

Study Start

January 31, 2025

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2028

Last Updated

April 22, 2026

Record last verified: 2025-12

Locations

US(10)AU(2)