Experimental CAR-T therapy targets tough childhood leukemia
NCT ID NCT07338357
First seen Jun 25, 2026 · Last updated Aug 27, 2026 · Updated 3 times
Summary
This early-phase study tests a new treatment called CLL-1 CAR-T for children aged 3 to 18 with acute myeloid leukemia that has come back or not responded to standard therapy. Ten participants will receive an infusion of their own modified immune cells after chemotherapy. The main goal is to check safety, but researchers will also look for signs that the leukemia shrinks or disappears.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CLL-1 CAR-T cells
- What this could lead to
- If it works, this could point toward a new treatment option for children with hard-to-treat acute myeloid leukemia.
- What could go wrong
- This is a very early, small study (10 participants) focused on safety. The therapy may not work or could cause severe side effects.
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.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2026
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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3 to 18 years
- Sex
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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 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: 1. Voluntarily sign the ICF and are expected to complete the study's follow-up examinations and procedures. 2. Aged 3 to 18 years (inclusive), and body weight ≥10 kg. 3. Diagnosis of AML according to the 2016 WHO classification, meeting the diagnostic criteria for relapse and refractoriness as per the "Chinese Guidelines for Diagnosis and Treatment of Relapsed/Refractory Acute Myeloid Leukemia (2017 Edition)", and currently having no clinically relevant treatment options or suitable registered clinical trials available. 4. Confirmation of CLL-1 expression ≥50% on AML blasts by flow cytometry. 5. Recovery from toxicities of prior therapies. 6. Karnofsky score (for age ≥16 years) ≥70 or Lansky score (for age \<16 years) ≥50 at screening, and an expected survival \>3 months. 7. Suitable function of the liver, kidneys, hematological system, lungs and heart is required. 8. Females subjects of childbearing potential must have a negative blood pregnancy test at screening and agree to use effective contraception during the study and within 1 year after the last dose of study drug. 9. Male subjects with reproductive potential must agree to use barrier contraception or practice complete abstinence until 1 year after the last study treatment. 10. Eligible blood cell specimen can be provided. Exclusion Criteria: 1. Diagnosis of APL. 2. History of other malignancies within 3 years prior to screening, except for adequately treated carcinoma in situ of the cervix, papillary thyroid carcinoma, basal cell or squamous cell skin cancer, localized prostate cancer treated with radical surgery, and ductal carcinoma in situ treated with radical surgery. 3. Evidence of CNS involvement or cranial nerve pathology. 4. Subjects with active infections such as hepatitis B, hepatitis C, etc., are to be excluded. 5. Subjects with a history of severe allergies or known allergy to any drug component included in this study are to be excluded. 6. Subjects with severe cardiac diseases, refractory hypertension, active neurological autoimmune or inflammatory diseases, clinically significant active cerebrovascular disease, oncologic emergencies requiring urgent intervention, acute or chronic GVHD, or any uncontrolled infections requiring antibiotic therapy, etc., are unsuitable for enrollment. 7. Previous organ transplant or planned organ transplant (except for hematopoietic stem cell transplantation). 8. Received allo-HSCT within 6 weeks prior to screening. 9. Subjects who have recently undergone major surgery or plan to undergo major surgery, excluding diagnostic procedures and biopsies. 10. Subjects with severe mental disorders, alcoholism, or drug abuse. 11. Subjects who, in the judgment of the investigator, have other conditions that make them unsuitable for enrollment.
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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.
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