NCT04555811

FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL

FATE FT596 With Rituximab as Relapse Prevention in High Risk Patients After Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I multi-center study to evaluate the safety of FT596 when given with rituximab as relapse prevention in patients who have undergone an autologous hematopoietic stem cell transplant (auto-HSCT) for diffuse large or high-grade B cell lymphoma.

Detailed description

This study uses a single dose of the investigational product FT596 in the early post-transplant period. Rituximab or an FDA approved by biosimilar including Rituxan®, Truxima®, and Ruxience™ is given 48 to 72 hours prior to FT596. The goal of this study is to 1) establish a maximum tolerated dose (MTD) of FT596 when given 30 days after transplant and 2) to confirm the MTD and safety of giving a single dose of FT596 at Day 7 post-transplant starting at one dose level below the MTD identified at Day 30.

Conditions

• NHL
• Non Hodgkin Lymphoma
• Diffuse Large B Cell Lymphoma
• High-grade B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	FT596	FT596 is given 2-3 days after rituximab; however, it may be delayed for up to 7 days until all rituximab infusion related toxicities resolve to ≤Grade 1.
DRUG	Rituximab	Rituximab 375 mg/m\^2 is administered as an IV infusion per institutional standard of care and package insert on 2-3 days (48 to 72 hours) prior to the FT596 infusion

Timeline

• Start date: 2020-09-22
• Primary completion: 2023-02-08
• Completion: 2023-11-30
• First posted: 2020-09-21
• Last updated: 2024-07-09
• Results posted: 2024-07-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study