A phase 1, open label, multi-center trial of AB-205 in adults with Hodgkin or non-Hodgkin lymphoma who are in chemo-sensitive remission undergoing high-dose therapy, with or without radiation, and autologous stem cell transplantation (HDT-ASCT). Subjects will receive AB-205 infusion following autologous stem cell transfusion on Day 0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Engineered human umbilical vein endothelial cells
City of Hope Comprehensive Cancer Center
Duarte, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
UC San Diego Moores Cancer Center
San Diego, California, United States
Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
Time frame: 24 hours
Occurrence of adverse events grade ≥ 3 as assessed by CTCAEv5
Time frame: 100 days
Severity and duration of grade ≥ 3 mucosal toxicities including oropharyngeal mucositis, nausea, vomiting, and/or diarrhea.
Time frame: Day 0 to hospital discharge
Time to neutrophil engraftment
Time frame: First of three consecutive days after ASCT of absolute neutrophil count (ANC) > 500/μL
Time to platelet engraftment
Time frame: First of seven consecutive days after ASCT of platelet count ≥ 20,000/μL without transfusion support
Time to lymphoid recovery
Time frame: 14, 28 and 100 days post-ASCT
Progression-free survival
Time frame: 100 and 365 days post-ASCT
Non-relapse mortality
Time frame: 100 and 365 days post-ASCT
Overall survival
Time frame: 100 and 365 days post-ASCT
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The University of California San Francisco
San Francisco, California, United States
University of Michigan
Ann Arbor, Michigan, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
MD Anderson
Houston, Texas, United States