RecruitingAstrocytomaGlioblastomaProgressive Disease

First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma

Eligible age

18–75 yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

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About this study

This is a single center, first-in cancer-type phase I clinical trial of FT536 for adult patients with recurrent WHO Grade 4 astrocytoma, irrespective of IDH-mutational status, for which a standard of care repeat craniotomy for gross tumor resection at time of first or second recurrence is achievable. Per this treatment schema, FT536 will be administered once intratumorally

Sponsor: Masonic Cancer Center, University of Minnesota

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.

Where it's recruiting

Minnesota

Minneapolis

Source: ClinicalTrials.gov · NCT07560865 · last updated 2026-05-01