Clinical Study of CLL-1 CAR-T in the Treatment of Children With R/R AML (NCT07338357) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
Clinical Study of CLL-1 CAR-T in the Treatment of Children With R/R AML
10 participantsStarted 2026-01-05
Plain-language summary
A study to evaluate the safety and preliminary efficacy of CLL-1-targeted CAR-T cell therapy in children aged 3 to 18 years with relapsed or refractory acute myeloid leukemia (r/r AML).
Who can participate
Age range
3 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily sign the ICF and are expected to complete the study's follow-up examinations and procedures.
. Aged 3 to 18 years (inclusive), and body weight ≥10 kg.
. 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.
. Confirmation of CLL-1 expression ≥50% on AML blasts by flow cytometry.
. Recovery from toxicities of prior therapies.
. Karnofsky score (for age ≥16 years) ≥70 or Lansky score (for age \<16 years) ≥50 at screening, and an expected survival \>3 months.
. Suitable function of the liver, kidneys, hematological system, lungs and heart is required.
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an early Phase 1 trial primarily designed to measure safety and side effects of CLL-1 CAR-T therapy rather than effectiveness, what does that mean for weighing the potential risks against the possible benefits for my child?
2CAR-T therapy can cause serious reactions like cytokine release syndrome — how would the medical team monitor and manage those kinds of side effects in a child, and what support would be available if something went wrong?
3The trial isn't recruiting yet — given where my child is right now in their treatment, is the timeline realistic, and are there other relapsed or refractory AML options we should be pursuing in the meantime?
4CLL-1 is the specific target this CAR-T therapy is designed to attack — has my child's leukemia been tested to confirm it expresses CLL-1, and how does that affect whether this approach might even be relevant for them?
5Are there currently available standard treatments or other clinical trials for relapsed or refractory AML in children that might be a better first step before considering an early-phase experimental therapy like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Related Adverse Events
Timeframe: Up to 2 years.
Trial details
NCT IDNCT07338357
SponsorFirst Affiliated Hospital of Guangxi Medical University
. 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.
. Evidence of CNS involvement or cranial nerve pathology.
. Subjects with active infections such as hepatitis B, hepatitis C, etc., are to be excluded.
. Subjects with a history of severe allergies or known allergy to any drug component included in this study are to be excluded.
. 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.
. Previous organ transplant or planned organ transplant (except for hematopoietic stem cell transplantation).
. Received allo-HSCT within 6 weeks prior to screening.