The goal of this clinical trial is to learn if agenT-797 is safe to use on people undergoing allogenic hematological stem cell transplantation (SCT). The main questions it aims to answer are: * Is agenT-797 safe to use? * What medical problems do participants have when taking agenT-797? Participants will receive an infusion of agenT-797 about 7 days after their allogenic SCT.
This study is being done to assess the safety and determine the maximum tolerated dose (MTD) of allogeneic invariant natural killer T (iNKT) cell therapy (agenT-797) in patients undergoing allogeneic hematological SCT.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
22
agenT-797 is an off-the-shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT cells isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex vivo.
University of Wisconsin - Madison
Madison, Wisconsin, United States
Number Of Participants With Treatment-related Adverse Events
This will be determined by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0.
Time frame: Baseline through Day 29 post cell infusion
Number Of Dose-limiting Toxicities
Time frame: Baseline through Day 29 post cell infusion
Incidence of grade II-IV acute graft-versus-host disease (aGVHD)
Time frame: Baseline through Day 29 post cell infusion
Incidence of severe grade III-IV aGVHD
Time frame: Baseline through Day 29 post cell infusion
Progression-free Survival (PFS)
1-year PFS is the percentage of patients who are alive and whose cancer has not progressed within one year after receiving agenT-797.
Time frame: 12 months
Non-relapse Mortalilty (NRM)
NRM is percentage of patients who died without recurrent or progressive disease after allo-SCT.
Time frame: 12 months
Relapse-free Survival (RFS)
RFS is the length of time from agenT-797 administration until disease relapse or death.
Time frame: 12 months
Overall survival (OS)
OS is the time from agenT-797 administration until death due to any cause.
Time frame: 12 months
Immune reconstitution based on lymphocyte subset panel
Time frame: 12 months
Immunoglobulin levels
Immune reconstitution measured through quantitative immunoglobulin levels
Time frame: 12 months
Incidence of treatment-emergent adverse event (TEAE) infection
Time frame: Baseline to 29 days post cell infusion
Type of infection
Description of type of infection, e.g., bacterial, viral, or fungal.
Time frame: Baseline to 29 days post cell infusion
Donor Chimerism
Donor chimerism will be assessed and categorized as full/complete chimerism (DNA ≥ 95% donor in CD3+ compartment) or mixed chimerism (DNA \< 95% donor in CD3+ compartment).
Time frame: Baseline to 29 days post cell infusion
Absolute neutrophil count (ANC)
Time frame: Baseline to 29 days post cell infusion
Non-relapse mortality rate (NRM)
NRM is percentage of participants who died without recurrent or progressive disease within 100 days after allo-SCT.
Time frame: 100 days
Relapse rate
Relapse rate is percentage of participants who relapsed within 100 days after allo-SCT
Time frame: 100 days
GVHD incidence
GVHD incidence rate at day 100 post SCT is the percentage of participants who experienced GVHD within 100 days after allo-SCT
Time frame: 100 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.