AstrocytomaPhase 1NCT07560865
First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma
A Phase 1 study testing FT536, Biopsy/ Intratumoral Injection/ Gross Tumor Resection and Blood/ Cerebrospinal Fluid/ Tumor Pathology in people with Astrocytoma and Glioblastoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Astrocytoma, Glioblastoma, Progressive Disease
- What is being tested?
- FT536, Biopsy/ Intratumoral Injection/ Gross Tumor Resection and Blood/ Cerebrospinal Fluid/ Tumor Pathology
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2026to 1 Jun 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Elizabeth C. Neil, MD
Minneapolis, Minnesota, 55455
Elizabeth C. Neil, MD, 612-273-8383, neile@umn.edu
About this study
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
Read the detailed 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.
Per this treatment schema, FT536 will be administered once intratumorally. 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 and MICB (MICA/B) chimeric antigen receptor (CAR); c) high-affinity, non-cleavable CD16 receptor; and d) an interleukin (IL)-15/IL15 receptor alpha fusion protein.
Current neuro-oncology professional census accepts the practice of a 2-stage neurosurgical intervention when there are radiographic changes concerning for recurrent cancer. First, the region of radiographic concern is biopsied to histologically confirm recurrence versus pseudoprogression. If intraoperative pathology is consistent with recurrence, then FT536 will be injected with a total volume of 1 mL infused along the biopsy tract into the residual enhancing portion, but also into the nonenhancing portions if safe and feasible per the discretion of the operating neurosurgeon. Occurring 7- 14 days later, the patient will undergo maximum safe surgical resection and a post-operative safety MR brain imaging will be performed to assess neurosurgical outcome and potential local toxicity.
- Conditions
- Astrocytoma, Glioblastoma, Progressive Disease
- Being tested
- FT536, Biopsy/ Intratumoral Injection/ Gross Tumor Resection, Blood/ Cerebrospinal Fluid/ Tumor Pathology
- Medical subject headings
- Astrocytoma, Glioblastoma, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FT536Biological
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.
Biopsy/ Intratumoral Injection/ Gross Tumor ResectionProcedure or surgery
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/ Cerebrospinal Fluid/ Tumor PathologyDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Dose Level Cohort -1 | Experimental | FT536 1 x 10^7 cells/dose. Used only if excess toxicity encountered on dose level 1. Receives: Biological: FT536; Procedure: Biopsy/ Intratumoral Injection/ Gross Tumor Resection; Diagnostic Test: Blood/ Cerebrospinal Fluid/ Tumor Pathology |
| Dose Level Cohort 1 | Experimental | FT536 2 x 10^7 cells/dose Receives: Biological: FT536; Procedure: Biopsy/ Intratumoral Injection/ Gross Tumor Resection; Diagnostic Test: Blood/ Cerebrospinal Fluid/ Tumor Pathology |
| Dose Level Cohort 2 | Experimental | FT536 6 x 10^7 cells/dose Receives: Biological: FT536; Procedure: Biopsy/ Intratumoral Injection/ Gross Tumor Resection; Diagnostic Test: Blood/ Cerebrospinal Fluid/ Tumor Pathology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start23 Apr 2026
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstrocytomaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Fate Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560865
- Sponsor's protocol ID
- 2024LS061
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma
- ClinicalTrials.gov ID
- NCT07560865
- Acronym / sponsor ID
- 2024LS061
- Conditions
- Astrocytoma, Glioblastoma, Progressive Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Collaborators
- Fate Therapeutics
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Per this treatment schema, FT536 will be administered once intratumorally. 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 and MICB (MICA/B) chimeric antigen receptor (CAR); c) high-affinity, non-cleavable CD16 receptor; and d) an interleukin (IL)-15/IL15 receptor alpha fusion protein.
Current neuro-oncology professional census accepts the practice of a 2-stage neurosurgical intervention when there are radiographic changes concerning for recurrent cancer. First, the region of radiographic concern is biopsied to histologically confirm recurrence versus pseudoprogression. If intraoperative pathology is consistent with recurrence, then FT536 will be injected with a total volume of 1 mL infused along the biopsy tract into the residual enhancing portion, but also into the nonenhancing portions if safe and feasible per the discretion of the operating neurosurgeon. Occurring 7- 14 days later, the patient will undergo maximum safe surgical resection and a post-operative safety MR brain imaging will be performed to assess neurosurgical outcome and potential local toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Level Cohort -1 | Experimental | Biological: FT536, Procedure: Biopsy/ Intratumoral Injection/ Gross Tumor Resection, Diagnostic Test: Blood/ Cerebrospinal Fluid/ Tumor PathologyFT536 1 x 10^7 cells/dose. Used only if excess toxicity encountered on dose level 1. |
| Dose Level Cohort 1 | Experimental | Biological: FT536, Procedure: Biopsy/ Intratumoral Injection/ Gross Tumor Resection, Diagnostic Test: Blood/ Cerebrospinal Fluid/ Tumor PathologyFT536 2 x 10^7 cells/dose |
| Dose Level Cohort 2 | Experimental | Biological: FT536, Procedure: Biopsy/ Intratumoral Injection/ Gross Tumor Resection, Diagnostic Test: Blood/ Cerebrospinal Fluid/ Tumor PathologyFT536 6 x 10^7 cells/dose |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FT536FT536 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. | Biological | Dose Level Cohort -1, Dose Level Cohort 1, Dose Level Cohort 2 |
| Biopsy/ Intratumoral Injection/ Gross Tumor ResectionOn 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 | Procedure or surgery | Dose Level Cohort -1, Dose Level Cohort 1, Dose Level Cohort 2 |
| Blood/ Cerebrospinal Fluid/ Tumor PathologyBlood 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 | Diagnostic test | Dose Level Cohort -1, Dose Level Cohort 1, Dose Level Cohort 2 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FT536, Biopsy/ Intratumoral Injection/ Gross Tumor Resection and Blood/ Cerebrospinal Fluid/ Tumor Pathology in people with Astrocytoma and Glioblastoma, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.