On June 7, 2023 Fate Therapeutics, Inc. (the "Company") reported that it will present at the 2023 Jefferies Healthcare Conference. The presentation will provide a business update, including a regulatory and clinical update on its FT522 program (Press release, Fate Therapeutics, JUN 7, 2023, View Source [SID1234632559]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The Company previously disclosed on May 3, 2023 that it had submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to investigate the safety and activity of FT522 in combination with CD20-targeted monoclonal antibody therapy in patients with relapsed / refractory B-cell lymphoma. The Company’s IND application has been allowed by the FDA, and the Company is currently conducting study start-up activities at multiple clinical sites.
The dose-escalating Phase 1 clinical trial is designed to assess a three-dose schedule of FT522 in each of two regimens:
•
Regimen A – up to two treatment cycles, with each treatment cycle consisting of conditioning chemotherapy, a single dose of rituximab, and three doses of FT522.
•
Regimen B – up to two treatment cycles, with each treatment cycle consisting of a single dose of rituximab and three doses of FT522 (without conditioning chemotherapy).
Patient enrollment into Regimen A will commence utilizing a three-dose schedule of FT522 at 300 million cells per dose. Subject to clearance of dose-limiting toxicities at this initial dose level of Regimen A, patient enrollment into Regimen B will then commence utilizing a three-dose schedule of FT522 at 300 million cells per dose. Dose escalation of each regimen may proceed independently.