NCT07560865 First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma
| NCT ID | NCT07560865 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Masonic Cancer Center, University of Minnesota |
| Condition | Astrocytoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2026-04-23 |
| Primary Completion | 2028-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 9 participants in total. It began in 2026-04-23 with a primary completion date of 2028-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07560865 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Astrocytoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07560865 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07560865 currently recruiting?
Yes, NCT07560865 is actively recruiting participants. Visit ClinicalTrials.gov or contact Masonic Cancer Center, University of Minnesota to inquire about joining.
Where is the NCT07560865 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT07560865 clinical trial?
NCT07560865 is sponsored by Masonic Cancer Center, University of Minnesota. The trial plans to enroll 9 participants.