NCT05950334

FT522 With Rituximab in Relapsed/Refractory B-Cell Lymphoma (FT522-101)

A Phase 1 Study of FT522 in Combination With Rituximab in Participants With Relapsed/Refractory B-Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Fate Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 study of FT522 administered with rituximab in participants with relapsed/refractory B-cell lymphoma (R/R BCL). The primary objectives of the study are to evaluate the safety and tolerability of FT522 in combination with rituximab, and to determine the recommended phase 2 dose (RP2D) of FT522 in combination with rituximab; each objective will be assessed with or without conditioning chemotherapy.

Conditions

• Relapsed/Refractory B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	FT522	FT522 drug product is administered as an intravenous infusion on Days 1, 4 and 8 of a treatment cycle.
DRUG	Rituximab	Rituximab will be administered as an IV infusion on Day -4 of the treatment cycle.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered as an IV infusion at a dose of 500 mg/m\^2 on Day -5, Day -4, and Day -3 of the treatment cycle.
DRUG	Fludarabine	Fludarabine will be administered as an IV infusion at a dose of 30 mg/m\^2 on Day -5, Day -4, and Day -3 of the treatment cycle.
DRUG	Bendamustine	Bendamustine will be administered as an IV infusion at a dose of 90 mg/m\^2 on Day -5 and Day -4 of the treatment cycle. Bendamustine may be administered as an alternative to cyclophosphamide/fludarabine.

Timeline

• Start date: 2023-11-16
• Primary completion: 2025-06-06
• Completion: 2025-06-30
• First posted: 2023-07-18
• Last updated: 2025-08-22

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study