Immune cells injected into brain tumors: a new hope for kids?
NCT ID NCT05887882
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This early-phase trial tests whether natural killer (NK) cells from healthy donors can be safely injected into the brain tumors of children and young adults whose cancer has returned or is growing. The NK cells are specially treated to resist the tumor's defenses. The main goals are to find the safest dose and check for side effects. The study is currently on hold.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- natural killer cells from healthy donors
- What this could lead to
- If it works, this could point toward a new treatment option for children and young adults with hard-to-treat brain tumors.
- What could go wrong
- This is a very early phase I trial with only 24 participants, so safety and dosing are still being figured out. It is currently suspended, and there is no guarantee it will lead to an effective treatment.
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 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2027
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 38 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 a histologically-confirmed recurrent or progressive malignant brain tumor including, but not limited to, infant-type hemispheric glioma, gliosarcoma, intracranial sarcoma and WHO Grade II ependymoma. 2. Participants should be candidates for resection of the recurrent tumor and be deemed candidate for placement of an Ommaya reservoir placed intra-cavitary/intra-tumoral; measurable residual tumor after surgery is not required for study entry. Pre-operative imaging needs to estimate that the resection cavity will be at least 2 cm x 2 cm in two dimensions for participants to be eligible. 3. Given the lack of a standard of care treatment for children with recurrent or progressive malignant brain tumors, participants must have completed first-line treatment with radiation and/or chemotherapy prior to participating in this trial if applicable. 4. All participants must be ≥ 1 year of age and ≤ 39 years of age at the time of entry into the study. The first 3 participants must be ≥ 8 years of age and ≤ 39 years of age at the time of entry into the study. 5. Performance Score: Karnofsky ≥ 50 for participants \> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. 6. Must have recovered from the acute toxic effects of prior therapy (i.e., NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5, grade 1 or less) * An interval of at least 12 weeks must have elapsed since the completion of radiation therapy. * Chemotherapy/biologic therapy: All cytotoxic chemotherapy/biologic therapy must be discontinued ≥ 7 days prior to enrollment (except 3 weeks for temozolomide and 6 weeks from last dose of nitrosoureas) * Immunotherapy: The last dose of anti-tumor antibody therapy must be at least 3 half-lives or 30 days, whichever is shorter, from the time of enrollment * For targeted agents only, participants should have recovered from any toxicity of the agent and have a minimum of 2 weeks since the last dose. * For participants who have received prior bevacizumab, at least 4 weeks is required. 7. Organ Function Requirements: 1. Adequate Bone Marrow Function Defined as: * Peripheral absolute neutrophil count (ANC) \>750/mm\^3. * Platelet count \>75,000/mm\^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to registration). 2. Adequate Renal Function Defined as: * A serum creatinine ≤ 1.5 x upper limit normal (ULN) based on age/gender. 3. Adequate Liver Function Defined as: * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin ≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN. * Alanine aminotransferase (ALT) ≤ 3 x ULN. * Aspartate aminotransferase (AST) ≤ 3 x ULN. 4. Adequate Neurologic Function Defined as: * Participants with seizure disorder may be enrolled if seizures are well-controlled. Participants on non-enzyme inducing anticonvulsants may be excluded pending interaction(s) with study drug. * Signs and symptoms of neurologic deficit must be stable for ≥ 1 week prior to registration. 8. The effects of Transforming growth factor beta resistant (TGFβi) natural killer (NK) cells on the developing human fetus are unknown. For this reason and because TGFβi NK cells as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and 6 months after completion of TGFβi NK cells administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. 9. Participants must enroll on PNOC COMP if PNOC COMP is open to accrual at the enrolling institution 10. A legal parent/guardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate. 11. Corticosteroids: Participants who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to registration. The patient steroid dose should be no more than a steroid-equivalent of dexamethasone 0.1 mg/kg/day (or maximum 4 mg/day; whichever is the lower dose) at time of enrollment. Exclusion Criteria: 1. Tumor involvement that would require ventricular or brainstem injection or access through a ventricle or significant risk of ventricular penetration in order to deliver the TGFβi NK cells. 2. Participants undergoing needle or open biopsy. 3. Participants who are receiving any other investigational agents. 4. Women of childbearing potential must not be pregnant or breast-feeding. 5. Evidence of active uncontrolled infection or unstable or severe intercurrent medical conditions. 6. Any medical condition that precludes surgery. 7. Prothrombin time/international normalized ratio (PT/INR) or partial thromboplastin time (PTT) \> 1.5 x ULN. 8. Participants with a known disorder that affects their immune system, such as human immunodeficiency virus (HIV), or an auto- immune disorder requiring systemic cytotoxic or immunosuppressive therapy are not eligible. 9. Evidence of bleeding diathesis or use of anticoagulant medication or any medication which may increase the risk of bleeding. If the medication can be discontinued \>1 week prior to NK cell infusion then the subject may be eligible following consultation with the Study Chairs. 10. Participants with significant systemic or major illnesses including but not limited to: congestive heart failure, ischemic heart disease, kidney disease or renal failure, organ transplantation, or significant psychiatric disorder. 11. History or current diagnosis of any medical or psychological condition that in the Investigator's opinion, might interfere with the participants ability to participate or inability to obtain informed consent because of psychiatric or complicating medical problems. Important note: The eligibility criteria listed above are interpreted literally and cannot be waived.
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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
10 sites. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Children's Hospital Los Angeles
Los Angeles, California, 90027, United States
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Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
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Indiana University
Indianapolis, Indiana, 46202, United States
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Johns Hopkins
Baltimore, Maryland, 21287, United States
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Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
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Seattle Children's
Seattle, Washington, 98105, United States
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The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
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University of Alabama Birmingham
Birmingham, Alabama, 35294, United States
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University of California, San Francisco
San Francisco, California, 94143, United States
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Washington University in Saint Louis
St Louis, Missouri, 63130, United States
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