Actively Recruiting
First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma
Led by Masonic Cancer Center, University of Minnesota · Updated on 2026-05-01
9
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
Sponsors
M
Masonic Cancer Center, University of Minnesota
Lead Sponsor
F
Fate Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed WHO Grade 4 astrocytoma from archival tissue with known IDH mutation and MGMT promoter methylation status
- Evidence of first or second cancer recurrence/progression by MRI suitable for gross tumor resection
- Completed standard of care antitumor treatment including surgery, radiation, and temozolomide +/- Tumor Treatment Fields
- No concurrent alternative curative therapy including Tumor Treatment Fields
- Able to undergo MRI scans with contrast throughout the study
- Age between 18 and 75 years at consent
- Karnofsky performance status of 70 or higher
- Off or on dexamethasone 2 mg daily or less with stable neurological function at enrollment
- Adequate organ function within 14 days before treatment
- Use of effective contraception for participants of childbearing potential or their partners from screening until 3 months post-treatment
- Agree to and sign consent for companion Long-Term Follow-Up study
- Provide voluntary written consent prior to any research procedures
- Agree to stay within 45-minute drive of the University of Minnesota from biopsy through hospital discharge after craniotomy
You will not qualify if you...
- Clinically significant increased intracranial pressure or uncontrolled seizures requiring urgent neurosurgical intervention
- History or features suggestive of myelodysplastic syndrome or acute myeloid leukemia
- Radiographic evidence of leptomeningeal disease
- Prior treatment with bevacizumab or any cellular therapy
- Non-malignant CNS diseases such as vasculitis or neurodegenerative disorders
- Prior or current use of GammaTile, Gliadel wafers, other implanted therapeutic agents, or photodynamic therapy
- Any condition requiring systemic immunosuppressive therapy (inhaled/topical steroids allowed)
- Pregnant or breastfeeding; menstruating participants must have negative pregnancy test within 14 days before biopsy and use effective contraception
- Known HIV seropositive or hepatitis B/C infection with detectable viral load
- Prior malignancy within 5 years except certain skin or in situ cancers or prostate cancer treated with surgery or radiation with low PSA
- Uncontrolled intercurrent illnesses including active infections or unstable heart conditions
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Elizabeth C. Neil, MD
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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