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
52 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
Researchers are evaluating FT536, a new type of natural killer (NK) cell immunotherapy, in adult patients with recurrent WHO Grade 4 astrocytoma, a severe brain tumor. This Phase I trial includes patients eligible for repeat brain surgery at the time of their first or second tumor recurrence, regardless of their IDH mutation status. The study aims to assess the safety and tolerability of this treatment over one year. FT536 will be given as a single injection directly into the tumor during surgery. The treatment involves three dose levels, ranging from 10 million to 60 million cells. Initially, the suspicious tumor area will be biopsied to confirm recurrence, followed by injection of FT536. About one to two weeks later, patients will have a second surgery to remove as much tumor as safely possible. Postoperative MRI scans will assess surgical outcomes and possible side effects. Participants will undergo blood tests to evaluate their immune cells and cytokines throughout the study. Cerebrospinal fluid samples will also be collected at several points to analyze immune responses. The research team will compare tumor tissue before and after FT536 injection to study the treatment's movement, replication, and impact on tumor cells and the immune environment. The entire participation period includes initial biopsy, FT536 injection, tumor removal surgery, and follow-up assessments for safety and immune monitoring.
CONDITIONS
Brief 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 tumor recurrence or progression by MRI where gross tumor resection is feasible
- Previous completion of standard treatments including surgery, radiation, and temozolomide with or without Tumor Treatment Fields
- No current alternative curative therapies including Tumor Treatment Fields
- Able to undergo MRI scans with contrast during the study
- Age between 18 and 75 years at consent
- Karnofsky performance status of 70 or higher
- On dexamethasone 2mg daily or less with stable neurological function at enrollment
- Adequate organ function within 14 days before study treatment
- Use of highly effective contraception for participants of childbearing potential or their partners from screening until 3 months after FT536 dose
- Agree to and sign consent for companion Long-Term Follow-Up study
- Provide voluntary written consent prior to research procedures
- Willing to stay within 45 minutes of the study site 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 central nervous system diseases such as vasculitis or neurodegenerative disorders
- Prior or current use of GammaTile, Gliadel wafer, other implanted therapies, or photodynamic therapy
- Conditions requiring systemic immunosuppressive therapy, except inhaled or topical steroids
- Pregnant or breastfeeding; negative pregnancy test required for menstruating participants of childbearing potential
- Known HIV, Hepatitis B or C infection with detectable viral load
- Prior malignancy within 5 years except certain skin, cervical, breast in situ, or treated prostate cancers
- Uncontrolled intercurrent illnesses including active infections, symptomatic heart failure, or unstable angina
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants undergo a biopsy to confirm cancer recurrence, followed by a single intratumoral injection of FT536. Between 7 to 14 days later, participants have maximum safe surgical resection of the tumor. Post-operative safety MRI brain imaging is performed to assess surgical outcomes and potential local toxicity.
2 to 3 visits (in-person) including biopsy and surgery visits
Duration - Up to 1 year
Participants undergo blood and cerebrospinal fluid sampling at several time points to monitor immune response and treatment effects, including analysis of tumor pathology before and after injection.
Multiple visits for blood and cerebrospinal fluid sampling over the year
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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