FT596

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P1b, N=0, Withdrawn, Fate Therapeutics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

Induced pluripotent stem cell (iPSC)-derived immune effector cells offer distinct advantages over existing patient- and donor-derived therapeutic approaches, including the use of a clonal master engineered iPSC line as a renewable source for the mass production of immune cells, which are available off-the-shelf for broad patient access...FT596 is currently being investigated as a monotherapy and in combination with the anti-CD20 mAbs rituximab and obinutuzumab in a multicenter, Phase I clinical trial for the treatment of relapsed/refractory B-cell lymphoma and chronic lymphocytic leukemia...The patient received fludarabine and cyclophosphamide lympho-conditioning followed by a single administration of 30 million cells of FT596 as monotherapy...Additional clinical, pharmacokinetic, and pharmacodynamic data from this patient will be provided at the time of the meeting. The Phase I trial is ongoing and is registered on clinicaltrials.gov: NCT04245722.

P1, N=50, Recruiting, Masonic Cancer Center, University of Minnesota | Not yet recruiting --> Recruiting

P1, N=50, Not yet recruiting, Masonic Cancer Center, University of Minnesota

The use of induced pluripotent stem cells (iPSCs) to derive immune effector cells offers distinct advantages for immune therapy over existing patient- or donor- derived platforms, not only in terms of scalable manufacturing and precision genetic engineering at the clonal level, but also in allowing the generation and combinational use of multiple effector cell types each with distinct characteristics. FT596 also shows enhanced clearance of CD19+CD20+ Burkitts lymphoma cell line RAJI when used in combination with rituximab (p=0.0002 vs rituximab alone). Collectively, these studies suggest a compounded anti-tumor effect can be achieved utilizing the inherent properties of engineered CAR-iNK cells together with therapeutic antibody combined with engineered CAR-iT cells which will be highlighted in this presentation.