First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT07560865
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • FT536 — BIOLOGICAL
    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 Resection — PROCEDURE
    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 Pathology — DIAGNOSTIC_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 Details

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

Key Dates

Start date
Apr 23, 2026
Status verified
Apr 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2029

Study Design

Enrollment
9 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level Cohort -1
    FT536 1 x 10\^7 cells/dose. Used only if excess toxicity encountered on dose level 1.
  • Experimental: Dose Level Cohort 1
    FT536 2 x 10\^7 cells/dose
  • Experimental: Dose Level Cohort 2
    FT536 6 x 10\^7 cells/dose

Primary Outcome Measure

Safety and Tolerability [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Elizabeth C. Neil, MDMinneapolisMinnesota55455
Elizabeth C. Neil, MD
[email protected]
612-273-8383

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By research site
Elizabeth C. Neil, MD· Minneapolis, MN

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