Correlated Drug Terms (0)

Correlated MeSH Terms (1)

Correlated HPO Terms (1)

Primary Outcomes

Description: An accelerated (fast-track) design will continue until first DLT is observed or the maximum Tolerated Dose (MTD) is determined. DLT is defined as any treatment emergent toxicity within 7 days after the last dose of FT516 meeting one of the following criteria based on CTCAE v5: Grade 3 or greater infusion related reaction following FT516 infusion Any new or worsening Grade 3 and any Grade 4 adverse events with the exception of the following known complications of COVID-19: Grade 3 gastrointestinal disorders (diarrhea) Grade 3 hepatic investigations (ALT increased, AST increased) Grade 3 leukopenia/lymphopenia Respiratory deterioration between the 1st dose and 7 days after the last dose of FT516 defined as the need for any type of assisted ventilation (invasive or non-invasive including BiPAP) or oxygen delivery device intended to deliver ≥60% FiO2 (including non-rebreather mask or >10L by simple facemask) to maintain an SpO2 >88%.

Secondary Outcomes

HP:0012418: Hypoxemia

Genes 14

Protein Mutations 2

SNP 0