NCT05934097

FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

A Phase 1b, Open-Label, Multicenter Study of FT596 in Combination With R-CHOP in Subjects With B-Cell Lymphoma

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diffuse Large B Cell Lymphoma
• Transformed Indolent Non-Hodgkin's Lymphoma
• Follicular Lymphoma
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma

Interventions

Type	Name	Description
DRUG	FT596	Dosing to be initiated at a dose no higher than highest tolerable dose in study FT596-101, intravenously
DRUG	Cyclophosphamide	750 mg/m\^2 intravenously
DRUG	Doxorubicin	50 mg/m\^2 intravenously
DRUG	Vincristine	1.4 mg/m\^2 (maximum dose 2 mg) intravenously
DRUG	Prednisone	100 mg orally
DRUG	Rituximab	375 mg/m\^2 intravenously
DRUG	Bendamustine	90 mg/m\^2 IV infusion

Timeline

• Start date: 2022-12-01
• Primary completion: 2026-05-01
• Completion: 2039-05-01
• First posted: 2023-07-06
• Last updated: 2023-07-06

Regulatory

• FDA-regulated drug study