First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma
1 other identifier
interventional
9
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2026
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 23, 2026
CompletedFirst Submitted
Initial submission to the registry
April 24, 2026
CompletedFirst Posted
Study publicly available on registry
May 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
May 1, 2026
April 1, 2026
2.1 years
April 24, 2026
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability
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
1 year
Study Arms (3)
Dose Level Cohort -1
EXPERIMENTALFT536 1 x 10\^7 cells/dose. Used only if excess toxicity encountered on dose level 1.
Dose Level Cohort 1
EXPERIMENTALFT536 2 x 10\^7 cells/dose
Dose Level Cohort 2
EXPERIMENTALFT536 6 x 10\^7 cells/dose
Interventions
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.
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
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
Eligibility Criteria
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.
- 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.
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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Masonic Cancer Center, University of Minnesotalead
- Fate Therapeuticscollaborator
Study Sites (1)
Elizabeth C. Neil, MD
Minneapolis, Minnesota, 55455, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2026
First Posted
May 1, 2026
Study Start
April 23, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
May 1, 2026
Record last verified: 2026-04