Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Cancer Refractory to Conventional Therapy

Inclusion Criteria

• •Pathologically confirmed diagnosis of refractory cancer that has failed at least prior line of conventional standard of care therapy.
• •Diagnosed with any histologically confirmed malignancy whose disease is confirmed to be metastatic and/or unresectable for which standard curative or beneficial treatments are no longer effective.
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• •≥ 4 weeks since any prior systemic therapy (excluding corticosteroid therapy) to treat the underlying malignancy (standard or investigational).
• •≥ 2 weeks since prior palliative radiotherapy.
• •Complete recovery to baseline or Grade 1 NCI CTCAE v5.0 from AE of prior surgery, radiotherapy, endocrine therapy, and other therapy as applicable, with exception of grade 2 alopecia from prior chemotherapy.
• •Adequate bone marrow function:
• •* Neutrophils: ≥ 1.5 K/µL without colony-stimulating factor support
• •* Platelet Count: ≥ 100 K/µL
• •* Hemoglobin: ≥ 9.0 g/dL without need for hematopoietic growth factor or transfusion support
• •* No ongoing transfusion requirements
• •Adequate hepatic function:
• •* Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), does not apply to patients with Gilbert's syndrome
• •* Serum albumin ≥ 3.0 g/dL
• •* ALT and AST ≤ 2.5 × ULN, unless hepatic metastases are present then \< 5 x ULN
• •Adequate renal function with creatinine ≤ 2.0 mg/dL.
• •Coagulation: INR or aPTT ≤1.5 X ULN unless the subject is receiving anticoagulant therapy.
• •Adequate pulmonary function as assessed by pulse oximetry (\>92% oxygen saturation on room air).
• •Negative pregnancy test for women of childbearing potential (i.e., all women except those who are post menopause for ≥ 1 year or who have a history of hysterectomy or surgical sterilization) and agree to use of effective contraception (hormonal or barrier method of birth control) during study.
• •Male participants and female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception