New immune therapy aims to stop relapse in kids with aggressive T-Cell cancer
NCT ID NCT07476027
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
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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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
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Up to 18 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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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.
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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.
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- Chemotherapy showdown: which combo works best for T-Cell cancers in kids?
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- Double-Team attack: new CAR-T therapy targets two cancer markers to outsmart relapse
- Blood cancer transplant trial using banked donor marrow pulled before start