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Brief Title: FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
Official Title: A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma
Study ID: NCT05934097
Brief Summary: This is a Phase I study of FT596 in combination with two different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will consist of a dose-escalation stage followed by a dose-expansion stage.
Detailed Description: This is a Phase I study of FT596 in combination with 2 different schedules (standard or alternate) of R-CHOP in subjects with B-cell lymphoma who are previously untreated or have received no more than one prior line of treatment. The study will evaluate both the clinical benefit of FT596 when combined with R-CHOP given on a standard or alternate schedule. Subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage. After safety and tolerability have been assessed to define the maximum tolerated dose (MTD) (or the maximum assessed dose \[MAD\] in the absence of dose limiting toxicities \[DLTs\] defining the MTD) in the dose-escalation stage, the dose-expansion stage will further evaluate the safety and activity of FT596 in combination.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Fate Trial Disclosure
Affiliation: Fate Therapeutics
Role: STUDY_DIRECTOR