Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07560865 | First-in Cancer-Type Phase I Study of FT536 for Recurrent WHO Grade 4 Astrocytoma | PHASE1 | RECRUITING | 9 | — | — | Apr 23, 2026 | Jun 1, 2029 | May 1, 2026 | 1 | United States |
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
| Arm | Type | Description |
|---|---|---|
| Dose Level Cohort -1 | EXPERIMENTAL | FT536 1 x 10\^7 cells/dose. Used only if excess toxicity encountered on dose level 1. |
| Dose Level Cohort 1 | EXPERIMENTAL | FT536 2 x 10\^7 cells/dose |
| Dose Level Cohort 2 | EXPERIMENTAL | FT536 6 x 10\^7 cells/dose |
| Name | Type | Description |
|---|---|---|
| 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 |
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 ...