FT538

P1, N=1, Terminated, Masonic Cancer Center, University of Minnesota | N=33 --> 1 | Trial completion date: Sep 2028 --> Aug 2024 | Suspended --> Terminated | Trial primary completion date: Sep 2026 --> Aug 2024; Product withdrawn from clinical development

Flow cytometric analysis revealed that FT538 iPSC-NKs induce AML cell death when combined with the AML therapies: cytarabine, venetoclax and gilteritinib. Moreover, cytarabine did not affect FT538 iPSC-NK viability, suggesting that iPSC-derived NK therapies and chemotherapy may be a promising treatment combination. This study provides the basis for further study of iPSC-derived NK cell therapies as a treatment option for high-risk AML patients, particularly those with disease resistant to standard therapies.

P1, N=9, Completed, Masonic Cancer Center, University of Minnesota | Trial completion date: Dec 2025 --> Oct 2024 | Active, not recruiting --> Completed

P1, N=0, Withdrawn, Masonic Cancer Center, University of Minnesota | N=34 --> 0

P1, N=33, Suspended, Masonic Cancer Center, University of Minnesota | Recruiting --> Suspended

P1, N=11, Active, not recruiting, Masonic Cancer Center, University of Minnesota | Trial primary completion date: Dec 2025 --> Jan 2024

P1, N=11, Active, not recruiting, Masonic Cancer Center, University of Minnesota | Recruiting --> Active, not recruiting | N=50 --> 11

iPSC-derived NK therapy offers a standardized, off-the-shelf option for NK cell therapies. FT538 iPSC-derived NK cells induce apoptosis in AML cell lines and patient samples in a dose-dependent manner and show a synergistic effect with Venetoclax, Gilteritinib, Azacitidine, and Cytarabine. Therefore, iPSC-derived NK cell therapy may be a promising possibility for AML treatment, particularly for patients resistant to standard therapies.

We hypothesized that the addition of Dara to fludarabine and cyclophosphamide would enhance lymphodepletion and augment ADCC for CD38+ AML leading to better response rates when combined with FT538. FT538 in combination with daratumumab has been tolerated in a highly pre-treated cohort of patients with expected toxicities and a signal of efficacy.

P1, N=16, Terminated, Fate Therapeutics | Trial completion date: Aug 2025 --> Aug 2023 | Active, not recruiting --> Terminated; This study was terminated by the Sponsor.

P1, N=16, Active, not recruiting, Fate Therapeutics | Recruiting --> Active, not recruiting | N=189 --> 16

In Regimen B, conditioning chemotherapy (fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2) followed by 3 once-weekly doses of FT538 (Days 1, 8, 15 of a 28-d cycle), ranging from 100 million cells/dose up to 1.5 billion cells/dose, are being evaluated using a standard 3 + 3 dose-escalation design. Administration of up to 3 doses of FT538 cells at 100 or 300 million cells/dose in combination with daratumumab is safe and well tolerated without CRS, neurotoxicity, or GvHD. Interim clinical data, including safety and tolerability and initial anti-tumor activity from the ongoing Phase I dose-escalation study of FT538 in combination with daratumumab in R/R MM, will be presented at the conference.