FT596 With Rituximab as Relapse Prevention After Autologous HSCT for NHL

General Information

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.
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.
Clinical trials phase Phase 1
Start date (estimated) 2020-09-22
End date (estimated) 2024-02-02
Clinical feature
Label non-Hodgkin lymphoma
Link http://purl.obolibrary.org/obo/DOID_0060060
Description A lymphoma that is characterized as any kind of lymphoma except Hodgkin's lymphoma.; OMIM mapping confirmed by DO. [LS].

Administrative Information

NCT number NCT04555811
ICTRP weblink https://trialsearch.who.int/Trial2.aspx?TrialID=NCT04555811
Other study identifiers
Name 2019LS230
Source weblink https://clinicaltrials.gov/ct2/show/NCT04555811
Public contact
Email ccinfo@umn.edu
Public email ccinfo@umn.educcinfo@umn.edu
Last name Cancer Center Clinical Trials Office
Phone +1 612 676-4200
City Minnesota
United States
Address freetext University of Minnesota, Masonic Cancer Center Minneapolis, Minnesota, United States, 55455
Sponsors Masonic Cancer Center, University of Minnesota


Which differentiated cell type is used
Label natural killer cell
Link http://purl.obolibrary.org/obo/CL_0000623
Description A lymphocyte that can spontaneously kill a variety of target cells without prior antigenic activation via germline encoded activation receptors and also regulate immune responses via cytokine release and direct contact with other cells.


Recruitment Status Active, not recruiting
Estimated number of participants 3