First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMasonic Cancer Center, University of Minnesota
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- FT536
- Biopsy/ Intratumoral Injection/ Gross Tumor Resection
- Blood/ Cerebrospinal Fluid/ Tumor Pathology
Treatment groups
9 Participants
are divided into 3 treatment groupsSponsors and collaborators
Masonic Cancer Center, University of Minnesota
Lead sponsor
Fate Therapeutics
Collaborator
Source ClinicalTrials.gov