CClinicalTrials.gg
RecruitingNCT06514794Updated Sep 3, 2026

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 interventional study of WU-CART-007 in T-cell Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, sponsored by Allotera Therapeutics. Recruiting at 18 sites in 2 countries. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by Allotera Therapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
125
Allocation
Not applicable
Ages
6 Months and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • T-cell Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma

Keywords

  • CAR-T Therapy
  • Acute Leukemia
03

Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
125 participants (estimated)

Study arms

  • Experimental
    WU-CART-007

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

    Biological: WU-CART-007

Interventions

  • BiologicalWU-CART-007

    A single IV infusion of WU-CART-007

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 24 months

  2. MRD Pos Cohort - Response Rate

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

    Time frame: 24 months

06

Study locations

18 of 18 sites recruiting
  • City of Hope
    Duarte, California 91010, United States
    Recruiting
  • Children's Hospital Los Angeles
    Los Angeles, California 90027, United States
    Recruiting
  • Colorado Blood Cancer Institute
    Denver, Colorado 80218, United States
    • Alireza Eghtedar, M.D. · Principal investigator
    Recruiting
  • Children's National Hospital
    Washington D.C., District of Columbia 20010, United States
    Recruiting
  • H. Lee Moffitt Cancer Center and Research Institute Hospital
    Tampa, Florida 33612, United States
    Recruiting
  • Children's Hospital of Atlanta
    Atlanta, Georgia 30329, United States
    • Judson Russell · Contact · BMT@choa.org · 404-433-6653
    • Muna Qayed, MD · Principal investigator
    Recruiting
  • Washington University Saint Louis
    St Louis, Missouri 63108, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center -- Pediatrics
    New York, New York 10017, United States
    • Ramzi Khalaf · Contact · khalafr@mskcc.org
    • Kevin Curran, M.D. · Principal investigator
    Recruiting
  • Oncology Hematology Care
    Cincinnati, Ohio 45226, 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
  • TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy
    Nashville, Tennessee 37203, United States
    Recruiting
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
    • Elias Jabbour, M.D. · Principal investigator
    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
    • Adam Lamble, M.D. · Principal investigator
    Recruiting
  • Peter Mac Callum Cancer Institute
    Melbourne, Victoria 3000, Australia
    • Ashish Bajel, M.D. · Contact · pcctu.haema@petermac.org
    • PCCTU HaemA · Contact
    • Ashish Bajel, M.D. · Principal investigator
    Recruiting
  • Royal Children's Melbourne
    Melbourne, Victoria 3000, Australia
    Recruiting
07

Registry details

Key details

Study ID
NCT06514794
Lead sponsor
Allotera Therapeutics
Responsible party
Sponsor
First posted
Jul 23, 2024
Start date
Jan 31, 2025
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2028 (estimated)
Last update
Sep 3, 2026

Study contacts

Allotera Therapeutics Clinical Trials Clinical Trials
Contact
clinicaltrials@alloteratx.com
314-501-1968
Cherry Thomas, MD
study director · Allotera Therapeutics

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion