FT596 was well tolerated as monotherapy or with rituximab and induced deep and durable responses in patients with indolent and aggressive lymphomas and the RP2D was preliminarily identified to be 1·8 × 109 cells for three doses per cycle. This study supports that cell therapy using iPSC-derived, gene-modified NK cells is a potent platform for cancer treatment and suggests that such a platform might address limitations of currently available immune cell therapies, including manufacturing time, heterogeneity, access, and cost.

P1, N=7, Completed, Masonic Cancer Center, University of Minnesota | Active, not recruiting --> Completed

P1, N=98, Terminated, Fate Therapeutics | Trial completion date: May 2039 --> Sep 2023 | Active, not recruiting --> Terminated | Trial primary completion date: May 2024 --> Sep 2023; The study was terminated by the Sponsor.

P1b, N=0, Withdrawn, Fate Therapeutics

P1, N=98, Active, not recruiting, Fate Therapeutics | Recruiting --> Active, not recruiting | N=552 --> 98

P1, N=3, Active, not recruiting, Masonic Cancer Center, University of Minnesota | Terminated --> Active, not recruiting | Trial completion date: Feb 2023 --> Feb 2024

P1, N=3, Terminated, Masonic Cancer Center, University of Minnesota | N=50 --> 3 | Trial completion date: Oct 2025 --> Feb 2023 | Suspended --> Terminated | Trial primary completion date: Oct 2025 --> Feb 2023

P1, N=50, Suspended, Masonic Cancer Center, University of Minnesota | Recruiting --> Suspended

P1, N=552, Recruiting, Fate Therapeutics | N=285 --> 552

Conditioning chemotherapy (fludarabine 30 mg/m 2 and cyclophosphamide 500 mg/m 2 on Days -5 to -3) is administered followed by a single dose of FT596 as monotherapy (Regimen A) or combined with rituximab (R) 375 mg/m 2 (Regimen B1) or obinutuzumab 1000 mg/m 2 (Regimen B2) on Day -4. FT596 monotherapy or in combination with R was well tolerated and demonstrated activity in pts with R/R BCL, including in pts previously treated with CAR T-cell therapy. Administration of a second FT596 treatment cycle was well tolerated with evidence of continuing clinical benefit. Dose escalation of FT596 is ongoing.

Treatments for B - cell malignancies have improved over the past several decades with clinical application of the CD20-specific antibody rituximab and chimeric antigen receptor (CAR) T cells targeting CD19. Further, these data suggest that iDuo NK cells may have an additional advantage over anti-CD19 CAR T cells by discriminating between healthy and malignant B cells. The first iDuo NK cell, FT596, is currently being tested in a Phase I clinical trial (NCT04245722) for the treatment of B-cell lymphoma.

P1, N=285, Recruiting, Fate Therapeutics | N=123 --> 285 | Trial completion date: Apr 2037 --> May 2039 | Trial primary completion date: Apr 2022 --> May 2024