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Donor immune cells take on tough T-Cell cancers in new trial

NCT ID NCT06514794

Disease control Sponsor: Allotera Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 4 times

Summary

This phase 2 trial tests a one-time infusion of WU-CART-007, a CAR-T cell therapy made from healthy donor cells, in 125 people with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that has come back or not responded to treatment. The goal is to see if it can wipe out cancer cells completely, including those too few to detect with standard tests. Participants must be at least 6 months old and in fairly good health aside from their cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
WU-CART-007 (a type of CAR-T cell therapy made from donor cells)
What this could lead to
If successful, this could offer a new treatment option for people with hard-to-treat T-cell leukemia or lymphoma, potentially leading to long-term remission.
What could go wrong
This is an early-phase trial with only 125 participants, so results may not apply to everyone. CAR-T therapies can cause serious side effects like cytokine release syndrome or nervous system problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 125 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 months and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

lymphoblastic lymphoma Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma T-cell acute lymphoblastic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoblastic lymphoma T-cell acute lymphoblastic leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital Los Angeles

    RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Atlanta

    RECRUITING

    Atlanta, Georgia, 30329, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19390, United States

  • Children's National Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20010, United States

  • Cincinnati Children's Hospital Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Colorado Blood Cancer Institute

    RECRUITING

    Denver, Colorado, 80218, United States

  • H. Lee Moffitt Cancer Center and Research Institute Hospital

    RECRUITING

    Tampa, Florida, 33612, United States

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Memorial Sloan Kettering Cancer Center -- Pediatrics

    RECRUITING

    New York, New York, 10017, United States

  • Oncology Hematology Care

    RECRUITING

    Cincinnati, Ohio, 45226, United States

  • Peter Mac Callum Cancer Institute

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Royal Children's Melbourne

    RECRUITING

    Melbourne, Victoria, 3000, Australia

  • Sarah Cannon Transplant and Cellular Therapy Methodist Hospital

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Sarah Cannon, Virginia Oncology Associates

    RECRUITING

    Norfolk, Virginia, 23502, United States

  • Seattle Children's Hospital

    RECRUITING

    Seattle, Washington, 98105, United States

  • TriStar Bone Marrow Transplant / Sarah Cannon Transplant & Cellular Therapy

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Washington University Saint Louis

    RECRUITING

    St Louis, Missouri, 63108, United States

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