Engineered immune cells take on deadly childhood brain cancer
NCT ID NCT07513194
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests a new treatment for children with a rare, aggressive brain tumor called ATRT that has come back or not responded to standard therapy. The treatment uses the patient's own immune cells, modified in a lab to better recognize and attack the tumor, plus added signals to help them survive longer. The main goals are to find a safe dose and check for side effects.
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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 21 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2044
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 21 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.
Procurement Inclusion Criteria: * 1\) Diagnosis of GPC3-positive recurrent ATRT. * 2\) Age ≥ 6 months * 3\) Karnofsky/Lansky score ≥ 60% * 4\) Informed consent explained to, understood by, and signed by patient/guardian; copy provided * 5\) GPC3 expression by immunohistochemistry with extent score ≥ Grade 2 (\>25% positive tumor cells) and intensity score ≥ 2 (scale 0-4) Procurement Exclusion Criteria: * 1\) No history of organ transplantation * 2\) No known HIV positivity * 3\) No active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections) * 4\) No other risk factors in which administration of the investigational agent is deemed not in the patient's best interest, in the opinion of the investigator Treatment Inclusion Criteria: * 1\) Age ≥ 6 months * 2\) Diagnosis of treatment refractory or unresectable ATRT after standard of care therapy * 3\) Lansky/Karnofsky score ≥ 60% * 4\) Stable neurologic exam for 7 days prior to enrollment * 5\) Stable or decreasing dose of steroids over past 7 days prior to surgery and administration of therapy (max allowable dose is 0.1mg/kg dexamethasone or equivalent per day) * 6\) Not receiving any concurrent anti-cancer therapy. * 7\) At least 6 weeks following craniospinal radiation therapy. * 8\) At least 14 days wash-out needed following small volume radiotherapy (i.e., Stereotactic Radiosurgery (SRS)). * 9\) At least 21 days or 5 half-lives (whichever is shorter) must have elapsed since any prior systemic therapy * 10\) Received any other forms of immunotherapy ≤ 42 days before administration of investigational agent * 11\) At least 28 days following bevacizumab * 12\) Creatinine clearance as estimated by Cockcroft Gault or Schwartz ≥ 60 ml/min * 13\) Total bilirubin \< 3 times ULN for age * 14\) INR ≤ 1.7 * 15\) Absolute neutrophil count \> 500/μl * 16\) Platelet count \> 100,000/μl (can be transfused but must be achieved prior to enrollment) * 17\) Hgb ≥ 7.0 g/dl (can be transfused) * 18\) Pulse oximetry \> 90% on room air * 19\) Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study * 20\) Sexually active patients must be willing to utilize one of the more effective birth control methods for 3 months after the T-cell infusion. * 21\) Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent Treatment Exclusion Criteria: * 1\) Pregnancy or lactation (for women at child-bearing age, birth control is required) * 2\) Uncontrolled infection * 3\) Known HIV positivity * 4\) Active bacterial, fungal or viral infection (except Hepatitis B or Hepatitis C virus infections) * 5\) History of organ transplantation
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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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Texas Children's Hospital
Houston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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