Gene-Edited stem cells may let doctors use stronger chemo against brain cancer
NCT ID NCT05052957
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times
Summary
This study tests a new approach for people with a recently removed glioblastoma (a fast-growing brain tumor). Doctors take some of the patient's own blood stem cells, add a protective gene (P140K MGMT) to them, and return them to the patient. This allows the use of higher doses of chemotherapy drugs (temozolomide and O6-benzylguanine) to kill more tumor cells while protecting the bone marrow from damage. The trial aims to see if this treatment is safe and helps patients live longer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2023
- Expected to finish
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Mar 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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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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants with histologically confirmed, newly diagnosed, supratentorial glioblastoma or gliosarcoma who have undergone tumor resection are eligible up to 35 days postoperatively. Participants with primarily infratentorial disease, or with multifocal, or leptomeningeal dissemination of disease will be excluded. In general, participants will not have \> 1 cm residual measurable or evaluable disease after surgical tumor resection. * Participant must have unmethylated MGMT * Absence of IDH1 or IDH2 mutation on tumor tissue by a CLIA-approved immunohistochemistry or DNA sequencing test on local testing. * Participants aged 18 years or older. * ECOG performance status 0-1or Karnofsky ≥ 70. * Life expectancy of at least 12 weeks. * No plan for hypofractionated radiation therapy * Adequate hematologic and hepatic function: * CBC/differential obtained within 28 days prior to registration: * Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 Note: the use of G-CSF or other intervention to achieve Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 is acceptable) * Platelets ≥ 50,000 cells/mm3 (Note: the use of transfusion or other intervention to achieve Platelets ≥ 50,000 cells/mm3 is acceptable) * Hemoglobin ≥ 9.0 g/dl (Note: the use of transfusion or other intervention to achieve Hgb ≥9.0 g/dl is acceptable) * Adequate hepatic function within 28 days prior to registration: * Bilirubin ≤ 3 ULN * ALT and AST ≤ 3 x ULN * Participants of child-bearing potential must agree to use single barrier contraception from time of trial entry to completion of the last cycle of chemotherapy. * Must be willing and able to understand and provide informed consent. * Participant must be considered to be clinically stable. * The participant will be identified as a candidate for an autologous transplant via an evaluation by a transplant physician per standard of care. * No evidence of active infection. * Participant must have the ability to understand and willingness to sign an informed consent document. Exclusion Criteria: * Any known medical or hereditary condition associated with immunosuppression; or other medical illness, which may jeopardize participant safety. * Pregnant or lactating women. There is data to indicate that BCNU and TMZ is teratogenic and carcinogenic. Thus, its use in pregnant women would confer unnecessary risk to the fetus. * Participants with a corrected DLCO or FEV1 \< 50% of predicted. * Participants with known diagnosis heart failure or cardiac insufficiency and an LVEF of \< 40%. * Inability to undergo repeated MRI evaluation; or allergy or intolerance of Gadoliniumcontaining contrast agent. * Active illicit drug use or diagnosis of active alcoholism. * Prior diagnosis of any malignant disease with the exception of non-melanomatous skin cancer, or carcinoma in situ of the cervix, bladder, prostate, or breast, unless the participant has been disease-free/in remission for ≥2 years prior to date of study enrollment. * Known human immunodeficiency virus infection or acquired immunodeficiency syndrome related illness. * Serologic status reflecting active hepatitis B or C infection. Individuals that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive individuals will be excluded).
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Genom att skicka in godkänner du våra Användarvillkor
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 study's own enquiry address
This study publishes an address for enquiries. See it below .
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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
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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University Hospitals Cleveland Medical Center
RECRUITINGCleveland, Ohio, 44106, United States
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