Engineered immune cells take on childhood cancers in first human test
NCT ID NCT06612645
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing a new type of cell therapy called B7H3-IL7Ra CAR T-cells in children and young adults (ages 1-25) whose solid tumors have returned or not responded to standard treatments. The therapy uses the patient's own immune cells, modified in a lab to better recognize and attack cancer cells. The main goal is to check safety, but researchers will also look for signs that the tumors shrink.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- B7H3-IL7Ra CAR T-cells (a type of immune cell therapy)
- What this could lead to
- If it works, this could point toward a new treatment option for children with hard-to-treat solid tumors that have come back after standard therapy.
- What could go wrong
- This is a very early Phase 1 trial with only 9 participants, so it is primarily testing safety. The therapy may not shrink tumors, and there are risks of serious side effects like cytokine release syndrome.
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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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 9 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2028
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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1 year to 25 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: 1. Participants must have B7-H3 positive solid tumor with measurable disease. \- B7-H3 expression will be evaluated by standard immunohistochemistry (IHC) or flow cytometry using a previously obtained sample. 2. Evidence of relapsed or refractory disease after standard first-line therapy 3. Age 1 - 25 years 4. Sex: Male or female 5. Performance status: Lansky or Karnofsky score not less than 50 6. Life expectancy not less than 12 weeks 7. Normal organ function * AST (SGOT) below 5 times the upper limit of normal (ULN) * ALT (SGPT) below 5 times the upper limit of normal (ULN) * Total bilirubin below 3 times the upper limit of normal (ULN) * Creatinine below 5 times the upper limit of normal (ULN) * SpO2 room air not less than 90% 8. Prior therapy wash-out before planned leukapheresis * Not less than 7 days post last chemotherapy/biologic therapy administration * 3 half-lives or 30 days, whichever is shorter after the last dose of antitumor antibody therapy * At least 30 days from most recent cellular infusion * All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with a maximum of 0.5 mg/kg/day dose of methylprednisolone. Corticosteroid physiologic replacement therapy is allowed 9. Participants and/or legal guardians must have the ability to understand and willingness to sign a written informed consent and/or assent document Exclusion Criteria: 1. Presence of greater than or equal to grade 3 cardiac dysfunction or symptomatic arrythmia requiring intervention 2. Presence of primary immunodeficiency or bone marrow failure syndrome 3. Presence of uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities, or psychiatric illness/social situations that would limit compliance with study requirements 4. Pregnant or breastfeeding women were excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study. Participants of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment in this study and for four months after receiving CAR-T-cell infusion. 5. Serologic status reflecting active HIV, hepatitis B or C infection. Participants who are positive for hepatitis B core antibody, hepatitis B surface antigen or hepatitis C antibody must have negative PCR prior to 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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King Chulalongkorn Memorial Hospital
RECRUITINGBangkok, Pathumwan, 10330, Thailand
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