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 leastprior line of conventional standard of care therapy.

• Diagnosed with any histologically confirmed malignancy whose disease is confirmed tobe metastatic and/or unresectable for which standard curative or beneficialtreatments 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) totreat 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 ofgrade 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 ortransfusion support

• No ongoing transfusion requirements

• Adequate hepatic function:

• Serum total bilirubin ≤ 1.5 × upper limit of normal (ULN), does not apply topatients 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 anticoagulanttherapy.

• Adequate pulmonary function as assessed by pulse oximetry (>92% oxygen saturation onroom air).

• Negative pregnancy test for women of childbearing potential (i.e., all women exceptthose who are post menopause for ≥ 1 year or who have a history of hysterectomy orsurgical sterilization) and agree to use of effective contraception (hormonal orbarrier method of birth control) during study.

• Male participants and female participants of childbearing potential who engage inheterosexual intercourse must agree to use protocol specified method(s) ofcontraception

Exclusion Criteria:

• Pregnant and/or lactating females.

• Life expectancy of less than three months.

• Currently being treated by "biological therapy" as defined by the National CancerInstitute (https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/bio-therapies-fact-sheet) Examples include checkpoint inhibitors, adoptive cell transfer, monoclonalantibodies, treatment vaccines, cytokines, CAR-T therapy, and natural killer (NK)cell therapy.

• Participants that are actively positive for COVID.

• Autoimmune disease requiring therapy; immunodeficiency, or any disease processrequiring immunosuppressive therapy, with exception to the following:

• intranasal, inhaled, topical steroids, or local steroid injection (e.g.,intra-articular injection);

• Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone orequivalent;

• Steroids as premedication for hypersensitivity reactions (e.g., CT scanpremedication).

• Prior clinical trial requiring participant to receive an investigational drug withinfour weeks of enrollment.

• Live vaccine within 30 days prior to enrollment.

• Clinically significant (i.e., active) cardiovascular disease: cerebral vascularaccident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 monthsprior to enrollment), unstable angina, congestive heart failure (≥ New York HeartAssociation Classification Class II), or serious cardiac arrhythmia requiringmedication.

• Mental or psychological illness preventing cooperation with treatment, efficacyevaluations.

• Participants who have undergone prior organ transplantation, including allogeneicstem-cell transplantation.