Experimental injection targets deadly brain cancer in early trial
NCT ID NCT07560865
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new drug called FT536 for adults with a severe type of brain cancer (WHO Grade 4 astrocytoma) that has come back. The drug is injected directly into the tumor during surgery. The main goal is to check safety and find the right dose in 9 participants.
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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 9 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jun 2029
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 to 75 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: * Histologically confirmed WHO Grade 4 astrocytoma from archival tissue. IDH mutation status and MGMT promoter methylation status will not limit candidacy but needs to be known. * Evidence of first or second cancer recurrence/ progression by magnetic resonance imaging (MRI) for which a gross tumor resection (GTR) is feasible as determined by the primary investigator in concordance with the study-affiliated neurosurgeon. * Previous completed SOC antitumor treatment including surgery, radiation therapy, and temozolomide +/- Optune/ Tumor Treatment Fields (TTF). * No concurrent alternative curative therapy, including use of TTF. * Able to undergo standard MRI scans with contrast agent throughout the course of the study. * ≥ 18 years and ≤ 75 years of age at the time of consent. * Karnofsky performance status ≥70. * Must be completely off or on a dose of dexamethasone 2mg daily or less with stable neurological function at the time of enrollment. * Adequate organ function within 14 days of study treatment start as defined in Section 4.1.9 of the protocol. * Participants of childbearing potential (POCBP) or with partners of childbearing potential must use a highly effective form of contraception from the time of the screening visit until at least 3 months after the dose of FT536. * Must agree to and sign the consent for the companion Long-Term Follow-Up study (CPRC# 2021LS077). * Voluntary written consent prior to the performance of any research related procedures. * Agree to stay in the Twin Cities metropolitan area (i.e. within a 45-minute drive of the UMN) from the time of biopsy through hospital discharge following completion of the planned craniotomy. Exclusion Criteria: * Clinically significant increased intracranial pressure (e.g., impending herniation or requirement for immediate palliative treatment) or uncontrolled seizures or any other situation requiring urgent neurosurgical intervention. * History of myelodysplastic syndrome (MDS)/ acute myeloid leukemia (AML) or with features suggestive of MDS/ AML. * Radiographic evidence of leptomeningeal disease. * Received prior treatment with bevacizumab or any other cellular therapy available on or off a clinical trial. * Non-malignant CNS disease such as CNS vasculitis or neurodegenerative disease. * Prior or current GammaTile, Gliadel wafer use, or other implanted therapeutic agent or photodynamic therapy. * Any known condition that requires systemic immunosuppressive therapy - inhaled and topical steroids are permitted. * Pregnant or breastfeeding. Menstruating POCBP must have a negative pregnancy test within 14 days before the planned biopsy. Patient must agree to use highly effective method of birth control from the time of the screening visit until at least 3 months after the dose of FT536. * Known seropositive for HIV or known Hepatitis B or C infection with detectable viral load by PCR. * Prior history of malignancy within 5 years of enrollment other than basal or squamous cell carcinoma of the skin, cervical intra-epithelial neoplasia, in situ carcinoma of the breast, or prostate cancer treated with surgery or RT with a prostate specific antigen of \<0.01 ng/mL tested within 28 days of trial enrollment. * Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pec
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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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Elizabeth C. Neil, MD
RECRUITINGMinneapolis, Minnesota, 55455, United States
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