Adverse events
nausea/vomiting, DLTs, fevers/chills, fatigue, diarrhea, fever, toxicities, toxicity, CRS, hematological toxicities, infection, hepatitis
INFECTION, HEPATITIS, ADVERSE EVENT, INFECTIONS AND INFESTATIONS
For DLs 1-2, common AEs were fatigue, hematological toxicities (decreased platelets, total white blood cells, lymphocytes, neutrophils), and CRS (grade 1-2). 1 patient experienced a VSV infection at DL2, seen as fevers/chills, fatigue, nausea/vomiting, diarrhea for ≥6 days. For DL3, common AEs were CRS (grade 1), hematological (decreased platelets and hemoglobin), increased liver function tests (LFTs), including increased AST and alanine aminotransferase (ALT). At DL4, AEs included fatigue, fever, CRS (grade 2-3), hematological toxicities (decreased platelets and lymphocytes), and AST elevation (Heat Map of Maximum Adverse Events by Dose Level. Dose limiting toxicities (DLTs) occurred at DL4 for 1 patient (A4.3). These included: decreased platelets (grade 3), increased AST (grade 3), CRS (grade 3). CRS criteria met due to organ toxicity of grade 3 hepatitis. The DLTs resolved within 14 days. Non-DLT AEs did not significantly increase with dose escalation. * Infections and infestations is defined as a condition.1 patient at DL4 experienced DLTs. These included: decreased platelet count (grade 3), increased aspartate aminotransferase (AST) (grade 3), and CRS (grade 3). CRS criteria was met due to organ toxicity of CTCAE grade 3 hepatitis. 3 patients in total were entered at DL4 with at least 14 days of observation for each patient prior to enrollment of the next patient.