Alanine aminotransferase≤2.5× ULN or ≤5× ULN if documented liver metastasisInability to follow the study procedures.Participation in another study with investigational drug within the 28 d or 5 half-lives of the drug, whichever is shorter, preceding and during the present study.
PBMCs were collected via leukapheresis using standardized procedures and cryopreserved following a controlled-rate freezing process. Manufacturing of a gavo-cel product was started a median of 11 d after leukapheresis . The manufacture of the gavo-cel product was carried out using the functionally closed CliniMACS Prodigy automated cell processing system at the Miltenyi Biotec manufacturing facility in San Jose, California.
. Study eligibility required biopsy tissue to express membranous mesothelin in at least 50% of the viable tumor cells at a staining intensity of 2+ or 3+.PBMCs were isolated from whole blood by density gradient centrifugation and cryopreserved.