Supercharged immune cells take on deadly brain tumors
NCT ID NCT07579208
First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times
Summary
This early-stage trial tests a new approach for people with recurrent glioblastoma, an aggressive brain cancer that has come back after standard treatment. Researchers will give patients specially engineered natural killer (NK) cells, either directly into the brain or through an IV, to see which method is safer. The study involves 36 adults and focuses on side effects and the best way to deliver the cells.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- engineered natural killer (NK) cells
- What this could lead to
- If it works, this could point toward a new treatment option for recurrent glioblastoma, a brain cancer with few options.
- What could go wrong
- This is a very early Phase 1 trial with only 36 people. It is designed mainly to check safety, not yet to prove the treatment works. There may be side effects from the cells or the delivery method.
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 36 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Jul 2030
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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18 years and older
- 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.
Eligibility Criteria 1. Male or female subjects aged ≥ 18 years. 2. Histologically confirmed supratentorial 2021 World Health Organization recurrent glioblastoma (IDH-wildtype GBM), gliosarcoma, or recurrent IDH-mutant WHO grade 4 astrocytoma, with any prior number of recurrences. 3. Have received prior radiation and temozolomide therapy. 4. Single tumor no larger than 5 cm in its greatest diameter. 5. Karnofsky Performance Status (KPS) score of \>70. 6. Has a baseline brain MRI obtained no more than 30 days prior to NK cell infusion 7. Adequate hematological function defined by white blood cell (WBC) count ≥ 3 x 10/L with absolute neutrophil count (ANC) ≥1.5 x109/L, lymphocyte count ≥ 0.5 x 109/L, platelet count ≥ 100 x 109/L, and Hgb ≥ 9 g/ dL (in absence of blood transfusion). 8. Adequate hepatic function defined by a total bilirubin level . 1.5 \~ ULN, an AST level ≤ 2.5 x ULN, and an ALT level ≤ 2.5 x ULN, and INR ≤ 1.5. 9. Adequate renal function defined by creatinine ≤ 1.5 X upper limit of normal (ULN) OR creatinine clearance ≥ 60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN. 10. Female subject of childbearing potential should have a negative serum pregnancy test. Subjects and their partners must be willing to use effective birth control during the study and for up to 3 months following last administration of NK cells. . 11. Prior Avastin use is allowed after at least a 12-week washout period. 12. Agree to sign consent to the long-term follow-up protocol PA17-0483 to fulfill the institutional responsibilities to various regulatory agencies. Exclusion Criteria 1. Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery. 2. Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks since last dose of agent administration. 3. Has known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCI-CTCAE v5.0), any history of anaphylaxis, within 5 months. 4. Has a known history of Human Immunodeficiency Virus (HIV) (positive HIV 1/2 antibodies); HTLV1 and/or HTLV2; active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected). Participants with prior HBV vaccination (anti-HBs positive, HBsAg negative, anti-HBc negative) will NOT be excluded. 5. Has a diagnosis of immunodeficiency or is receiving any immunosuppressive therapy (such as tacrolimus, cyclosporine, infliximab) within 7 days prior to study registration. 6. Has had prior chemotherapy or targeted small molecule therapy within 2 weeks prior to study Day 0 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent such as thrombocytopenia or platelets toxicity. Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study at the discretion of the treating investigator. 7. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include superficial tumors considered adequately treated locally with curative intent, including but not limited to basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. Any exceptions must be discussed with the protocol PI. 8. Has known Gliomatous meningitis or extracranial disease, or tumor localized primarily to the brainstem or spinal cord 9. Midline shift greater than 0.5 cm or pending herniation 10. Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Participants receiving epidural steroid injections for pain will be excluded. Subjects with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study. 11. Has evidence of interstitial lung disease or active, non-infectious pneumonitis 12. Has an active infection requiring systemic therapy or that in the opinion of the PI may interfere with the subject's participation, assessment of experimental treatment toxicity or increase the subject's risk of side effects 13. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate in the opinion of the treating investigator. 14. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial 15. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit and through 3 months after last dose of the study treatment 16. Has received a live vaccine within 30 days prior to the first dose of trial treatment 17. Has a contraindication for undergoing MRIs 18. Has evidence of bleeding diathesis or coagulopathy 19. Is on full dose anticoagulants or antiplatelet therapy that cannot be held (full dose depends on the actual anticoagulant) 20. Has significant hemorrhage on baseline scan defined as \>1 cm diameter of acute blood 21. Has received any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant) 22. Has multifocal disease. Subject has multifocal GBM, defined as discrete sites of contrast enhancing disease without contiguous T2/FLAIR abnormality that require distinct radiotherapy ports. Satellite lesions that are associated with a contiguous area of T2/FLAIR abnormality as the main lesion(s) and that are encompassed within the same radiotherapy port as the main lesion(s) are permitted.
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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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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Other studies related to the condition(s) this trial covers.
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