First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma (NCT07560865) | Clinical Trial Compass
RecruitingPhase 1
First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma
United States9 participantsStarted 2026-04-23
Plain-language 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
Who can participate
Age range18 Years – 75 Years
SexALL
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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 procedu…
What they're measuring
1
Safety and Tolerability
Timeframe: 1 year
Trial details
NCT IDNCT07560865
SponsorMasonic Cancer Center, University of Minnesota