Spots Global Cancer Trial Database for FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL
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Trial Identification
Brief Title: FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL
Official Title: FATE FT596 With Rituximab as Relapse Prevention in High Risk Patients After Autologous Hematopoietic Stem Cell Transplantation for Non-Hodgkin Lymphoma
Study ID: NCT04555811
Study Description
Brief 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Minnesota, Minneapolis, Minnesota, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
Contact Details
Name: Dr.Veronika Bachanova, MD, PhD
Affiliation: Masonic Cancer Center, University of Minnesota
Role: PRINCIPAL_INVESTIGATOR
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