study of allogeneic blood-derived natural killer cells to evaluate safety and tolerability in cancer refractory to conventional therapy

Conditions: Pathologically Confirmed Cancer Refractory to Conventional Therapy; Refractory Cancer; Metastatic Cancer; Recurrent Cancer; Solid Tumor, Adult; Solid Tumor; Advanced Cancer; Advanced Solid Tumor

Summary: the goal of this clinical trial is to test snk02 in participants with pathologically confirmed cancer that is refractory to conventional therapy. the main questions it aims to answer are: * is snk02 safety and tolerable when administered weekly as an intravenous infusion * what is the maximum dose that is tolerated of snk02 participants will be administered snk02 weekly for 8 weeks and undergo medical evaluation to provide initial clinical safety data for the treatment of cancer with allogeneic nk cells as a monotherapy treatment.


Eligibility criteria:
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 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 cancer institute (https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/bio-therapies-fact-sheet) examples include checkpoint inhibitors, adoptive cell transfer, monoclonal antibodies, 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 process requiring 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 or equivalent; * steroids as premedication for hypersensitivity reactions (e.g., ct scan premedication). * prior clinical trial requiring participant to receive an investigational drug within four weeks of enrollment. * live vaccine within 30 days prior to enrollment. * clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ new york heart association classification class ii), or serious cardiac arrhythmia requiring medication. * mental or psychological illness preventing cooperation with treatment, efficacy evaluations. * participants who have undergone prior organ transplantation, including allogeneic stem-cell transplantation.