NCT07560865 · Masonic Cancer Center, University of Minnesota
First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma
What this study 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 the usual treatment repeat craniotomy for gross tumor resection at time of first or second recurrence is achievable.
View original scientific description
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.
Interventions
BIOLOGICAL
FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy produced from a clonal master human induced pluripotent stem cell (iPSC) line with the following four engineered elements: a)deletion of the gene encoding CD38 (i.e., CD38 knockout); b) expression of the MICA andMICB (MICA/B) chimeric antigen receptor (CAR); c) high-affinity, non-cleavable CD16 receptor; and d) an interleukin (IL)-15/IL15 receptor alpha fusion protein.
PROCEDURE
Biopsy/ Intratumoral Injection/ Gross Tumor Resection
On Study Day 1, the region of radiographic concern is biopsied to histologically confirm cancer recurrence versus pseudoprogression. If intraoperative pathology is consistent with cancer recurrence, then FT536 will be injected with a total volume of 1 mL infused via a ventricular catheter placed along the biopsy tract. Occurring between Study Day 8-15, the patient will undergo maximum safe surgical resection
DIAGNOSTIC_TEST
Blood/ Cerebrospinal Fluid/ Tumor Pathology
Blood analysis will occur throughout the study to determine the quality of endogenous NK cells and T cells as well as cytokine concentrations. Cerebrospinal fluid sampling will occur at 2-3 time points throughout the study and the fluid will be analyzed for cytokines and immune cells. Compare pre- (from biopsy) versus post- (from resection) injection pathology to determine FT536 motility, replication ability, and impact on the microenvironment as well as malignant astrocytoma cell death plus the persistence of endogenous NK cells
Primary outcome measures
Safety and Tolerability
Time frame: 1 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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Minneapolis, Minnesota
Collaborators
Fate Therapeutics
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 1, 2026 · Source of record for eligibility and locations