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

{ "FT536 for Recurrent Grade 4 Astrocytoma", "This study is testing a new immunotherapy called FT536 for adults with recurrent WHO Grade 4 astrocytoma (a type of brain cancer). FT536 uses special immune cells called natural killer (NK) cells to fight cancer. You might be able to join if your cancer has come back once or twice and can be surgically removed. The study will look at how safe FT536 is and how well people tolerate it over one year. This is a small, early-stage study, aiming to enroll 9 participants, and its current status is unclear.", "design": "This is a single-center, Phase I study for a new cancer type, involving 9 participants. It is an interventional study, meaning participants will receive a specific treatment.", "commitments": "You would undergo a biopsy to confirm cancer recurrence. If confirmed, FT536 would be injected into the tumor during surgery. You would also have blood and cerebrospinal fluid (fluid around the brain and spinal cord) samples taken at different times.", "compensation": "Not stated in the trial record.", "follow_up": "The study will follow participants for safety and tolerability for one year after treatment.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07560865

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

Recruiting
PHASE1Ages 18–75InterventionalTreatment
Masonic Cancer Center, University of Minnesota
~9 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:FT536Biopsy/ Intratumoral Injection/ Gross Tumor ResectionBlood/ Cerebrospinal Fluid/ Tumor Pathology

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability
Measured over 1 year

Conditions

Astrocytoma
Glioblastoma
Progressive Disease

Explore related trials

Glioblastoma

Where it's being run

1 sites across 1 states
Minnesota1

Who to contact

Elizabeth C. Neil, MD
[email protected]
612-273-8383
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Safety and Tolerability1 year

    To determine the safety and tolerability of inter-cohort dose escalation intratumoral FT536 as outlined by incidence of adverse events (AEs) based on CTCAE v5.0