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New immune therapy aims to stop relapse in kids with aggressive T-Cell cancer

NCT ID NCT07476027

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase trial tests a single infusion of CD7 CAR-T cells in 10 children with high-risk T-cell acute lymphoblastic leukemia or lymphoma who have already achieved remission. The goal is to see if this immune cell therapy can safely eliminate remaining cancer cells and reduce the chance of relapse. Researchers will monitor side effects and treatment response closely.

What this could mean

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

Active substance
CD7 CAR-T cells (a type of immune cell therapy)
What this could lead to
If it works, this could help prevent relapse in children with high-risk T-cell leukemia/lymphoma after initial treatment.
What could go wrong
This is a very early, small trial (10 people) with no results yet. The therapy may cause severe side effects or fail to prevent relapse.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 10 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

Up to 18 years

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.

Inclusion Criteria: * Patients aged ≤18 years with newly diagnosed T-LBL/ALL. * Have completed induction chemotherapy and achieved CR1, with bone marrow MRD \< 0.01%. * High/very high-risk or poor induction response patients. * High risk of future relapse, and recommended by multidisciplinary team (MDT) evaluation for prospective lymphocyte collection and preparation. * Peripheral blood absolute lymphocyte count (ALC) ≥ 0.5×10⁹/L, and good general condition (ECOG score 0-1 or Lansky/Karnofsky score ≥ 80). * Legal guardian agrees to provide written informed consent. Infusion Criteria: * Essential normal function of major organs. * Left ventricular ejection fraction (LVEF) ≥ 45%. * Serum creatinine ≤ 1.5 × upper limit of normal (ULN) for age. * Serum total bilirubin, ALT/AST ≤ 3 × ULN (unless clearly related to leukemic infiltration). * No active, uncontrolled severe infection. Exclusion Criteria: * Severe cardiac or pulmonary insufficiency, which the investigator deems inappropriate for enrollment. * Complicated with other progressive malignant tumors. * Presence of active and/or uncontrolled infections that have not been effectively managed. * Complicated with severe autoimmune diseases or congenital immunodeficiency. * Active hepatitis \[positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), with HBV DNA copy number greater than the upper limit of normal at the study center; positive for anti-HCV, with HCV-RNA copy number greater than the upper limit of normal at the study center\]. * Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), syphilis infection.). * A history of severe hypersensitivity to biological products (including antibiotics). * Patients who have undergone allogeneic hematopoietic stem cell transplantation and still suffer from acute graft-versus-host disease (GVHD) one month after discontinuation of immunosuppressive agents. * Patients with other severe physical or mental diseases or abnormal laboratory test results that may increase the risk of study participation or interfere with study outcomes, as well as those who are deemed unsuitable for participation in this study by the investigator.

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Conditions

The condition(s) this trial relates to.

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

As listed by the trial registrant

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

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

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Other studies related to the condition(s) this trial covers.