Clinical trial Recruiting at 18 sites Phase 2 Interventional Ages 6 Months and up

WU-CART-007 anti-CD7 CAR-T for relapsed or MRD-positive T-cell ALL and lymphoblastic lymphoma

Official title: 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)

Run by Allotera Therapeutics · NCT06514794 · Data updated 2026-11-12

This trial will try WU-CART-007, an off-the-shelf anti-CD7 CAR-T therapy, in people with relapsed/refractory or MRD-positive T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma to see if it produces MRD-negative remissions.

More Lymphoblastic Lymphoma trials

Quick facts

PhasePhase 2
Study typeInterventional
Ages6 Months and up
SexAll
Enrollment125 (estimated)
SponsorAllotera Therapeutics
Industry-sponsored
Drugs / interventionsCART
Locations18 sites (Duarte, California and 17 other locations)
StatusRecruiting
StartedJanuary 31, 2025
Main results expectedDecember 30, 2026
Study endsDecember 30, 2028
Registry record updatedSeptember 28, 2026
Trial IDNCT06514794 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are people aged six months or older with relapsed/refractory T-ALL or T-LBL, or those in remission but still MRD-positive, who have adequate organ function and good performance status.

Probably not a fit

Patients who previously received anti-CD7 therapy, have decompensated hemolytic anemia, or have active grade 2–4 graft-versus-host disease requiring systemic immunosuppression are unlikely to be eligible or benefit from this therapy.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

WU-CART-007 is an allogeneic anti-CD7 CAR-T cell therapy designed to target T-cell malignancies. This Phase 2, single-arm, multi-center, open-label trial enrolls patients aged six months and older with relapsed/refractory T-ALL or T-LBL or those in remission but remaining MRD positive. Participants receive a WU-CART-007 infusion at one of the study centers and are followed for response, MRD status, durability of remission, and safety, including CAR-T–related toxicities and graft-versus-host disease. The primary goal is to see how often the therapy induces complete MRD-negative remissions, with secondary endpoints focused on durability and adverse events.

Why it matters

Potential benefit: If successful, WU-CART-007 could produce deep MRD-negative remissions and provide a new treatment option for patients with relapsed or MRD-positive T-cell ALL/LBL.

How similar studies have gone: Early-phase reports of anti-CD7 CAR-T approaches have shown promising responses in T-cell malignancies, but larger confirmatory trials remain limited.

Who can join: the full rules

Show full inclusion / exclusion 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) 0 or 1/Karnofsky Performance Status 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.

Where it's running

  • City of Hope
    Duarte, California, United States
    Recruiting
  • Children's Hospital Los Angeles
    Los Angeles, California, United States
    Recruiting
  • Colorado Blood Cancer Institute
    Denver, Colorado, United States
    Recruiting
  • Children's National Hospital
    Washington D.C., District of Columbia, United States
    Recruiting
  • H. Lee Moffitt Cancer Center and Research Institute Hospital
    Tampa, Florida, United States
    Recruiting
  • Children's Hospital of Atlanta
    Atlanta, Georgia, United States
    Recruiting
Show 12 more locations
  • Washington University Saint Louis
    St Louis, Missouri, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center -- Pediatrics
    New York, New York, United States
    Recruiting
  • Oncology Hematology Care
    Cincinnati, Ohio, United States
    Recruiting
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio, United States
    Recruiting
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania, United States
    Recruiting
  • TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy
    Nashville, Tennessee, United States
    Recruiting
  • MD Anderson Cancer Center
    Houston, Texas, United States
    Recruiting
  • Sarah Cannon Transplant and Cellular Therapy Methodist Hospital
    San Antonio, Texas, United States
    Recruiting
  • Sarah Cannon, Virginia Oncology Associates
    Norfolk, Virginia, United States
    Recruiting
  • Seattle Children's Hospital
    Seattle, Washington, United States
    Recruiting
  • Peter Mac Callum Cancer Institute
    Melbourne, Victoria, Australia
    Recruiting
  • Royal Children's Melbourne
    Melbourne, Victoria, Australia
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.