Table 1 Safety-related eligibility... | American Society of Hematology

Table 1

Safety-related eligibility criteria for adult CAR T-cell clinical trials at the NCI

Clinical category	Eligibility criteria
Patient characteristics	ECOG performance status 0-1; and
Patient characteristics	Not pregnant or breastfeeding
Pulmonary	No active obstructive or restrictive pulmonary disease
Hematologic*	Hemoglobin ≥8.0 g/dL;
	Platelets ≥45 000/mm³ without transfusion support;
	ANC ≥1000/mm³ without growth factor support;
	No active hemolytic anemia; and
	No active coagulopathy
Other end organ function	Serum creatinine ≤1.4 mg/dL;
	Total bilirubin ≤2.0 mg/dL;
	Serum AST and ALT ≤3 times the institutional upper limit of normal unless liver involvement by malignancy is demonstrated;
	No active seizure disorder; and
	No current CNS involvement with malignancy
Infectious disease	No history or serologic evidence of HIV, hepatitis B, or hepatitis C; and
Infectious disease	No active uncontrolled systemic infection
Immunologic	No active autoimmune disease; and
Immunologic	No history of primary immunodeficiency

Clinical category	Eligibility criteria
Patient characteristics	ECOG performance status 0-1; and
Patient characteristics	Not pregnant or breastfeeding
Pulmonary	No active obstructive or restrictive pulmonary disease
Hematologic*	Hemoglobin ≥8.0 g/dL;
	Platelets ≥45 000/mm³ without transfusion support;
	ANC ≥1000/mm³ without growth factor support;
	No active hemolytic anemia; and
	No active coagulopathy
Other end organ function	Serum creatinine ≤1.4 mg/dL;
	Total bilirubin ≤2.0 mg/dL;
	Serum AST and ALT ≤3 times the institutional upper limit of normal unless liver involvement by malignancy is demonstrated;
	No active seizure disorder; and
	No current CNS involvement with malignancy
Infectious disease	No history or serologic evidence of HIV, hepatitis B, or hepatitis C; and
Infectious disease	No active uncontrolled systemic infection
Immunologic	No active autoimmune disease; and
Immunologic	No history of primary immunodeficiency

ALT, alanine aminotransferase; ANC, absolute neutrophil count; AST, aspartate aminotransferase; ECOG, Eastern Cooperative Oncology Group.

Hematologic criteria must be met for enrollment regardless of bone marrow involvement with malignancy.