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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
7
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.
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
University of Minnesota
Minneapolis, Minnesota, United States
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States
Number of Participants Experiencing Dose Limiting Toxicity Events
The component I design (FT596 on day 30) will continue until the MTD is declared or until the first dose is declared to be above MTD. The component I dose limiting toxicity (DLT) is defined as any of the following events within 28 days after the FT596 dosing based on CTCAE v5:Grade 4 hematologic toxicity lasting \> 7 days ,Grade 4 non-hematologic toxicity ,Grade ≥3 Infusion Related Reaction, Grade 2 acute GVHD that requires steroid therapy \>7 days or progression after 3 days of steroids or has partial response after 14 days of treatment, Grade ≥3 acute GVHD, Grade 4 cytokine release syndrome (CRS), Grade 3 CRS that does not resolve to \< Grade 2 in 72 hours, Grade 3 neurotoxicity, Grade 3 organ toxicity involving vital organs, Any Grade 3 non-hematological toxicity that does not resolve to ≤Grade 2 within 72 hours
Time frame: 28 Days Post FT596 infusion
Number of Participants Experiencing Adverse Events
Number of participants experiencing adverse events related to FT596 post auto-HSCT in combination with rituximab
Time frame: 1 year post FT596 infusion
Percentage of Participants With Relapse/Progression
Percentage of participants experiencing progression or relapse at 12 months post auto HSCT
Time frame: 1 year post auto HSCT
Number of Participants Experiencing Non-relapse Mortality Incidents at 100 Days Post HSCT
Number of participants experiencing non-relapse mortality at 100 days post auto-HSCT.
Time frame: 100 days post HSCT
Percentage of Non-relapse Mortality Incidents at One Year Post HSCT
Percentage of participants experiencing non-relapse mortality at one year post auto-HSCT.
Time frame: one year post auto-HSCT
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Progression-Free Survival 12 Months Post Auto-HCT
Progression-Free Survival 12 Months Post Auto-HCT
Time frame: 12 Months Post Auto-HCT