Allogenic Blood-Derived Natural Killer Cells in Cancer Refractory to Conventional Therapy

What is the Purpose of this Study?

The purpose of this study is to evaluate a blood-derived experimental therapy in patients who have refractory cancer that has failed conventional, standard-of-care therapy. Researchers will use natural killer (NK) cells to create the study therapy called SNK02. SNK02 will be evaluated for safety and anti-tumor activity (ability to shrink tumors) as a single therapy (given alone). SNK02 is a cellular immunotherapy that is being studied for the treatment of advanced cancers to boost the immune system and help it recognize and get rid of cancer cells. It is made of NK cells that have been taken from a donor and then processed in a lab to multiply and increase the number of cells (known as an allogenic treatment). NK cells are an essential component of the immune system and have the ability to directly attack virally infected cells or cancer cells, as well as recruit other immune cells that are important for the immune defense in the body.

Eligibility

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).

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.

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Where can I participate?

Cedars-Sinai Cancer at The Angeles Clinic and Research Institute : Saba Mukarram

More about this Clinical Trial

What is the full name of this clinical trial?

SNK02-202: A Phase 1, Open-Label, Dose Escalation Study of Allogeneic Blood-derived Natural Killer Cells to Evaluate Safety and Tolerability in Participants with Pathologically Confirmed Cancer Refractory to Conventional Therapy

Study Details

Disease Type/Condition

Anus, Bones and Joints, Brain and Nervous System, Breast, Cervix, Colon, Corpus Uteri, Esophagus, Eye and Orbit, Hodgkin's Lymphoma, Ill-Defined Sites, Kaposi's Sarcoma, Kaposi's sarcoma, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Liver, Lung, Melanoma, Multiple Myeloma, Mycosis Fungoides, Non-Hodgkin's Lymphoma, Other Digestive Organ, Other Endocrine System, Other Female Genital, Other Male Genital, Other Respiratory and Intrathoracic Organs, Other Skin, Other Urinary, Ovary, Pancreas, Prostate, Rectum, Small Intestine, Soft Tissue, Stomach, Thyroid, Unknown Sites, Urinary Bladder

Principal Investigator

Hamid, Omid

Co-Investigators

Ani Balmanoukian, Cathie T Chung, Inderjit Mehmi, Iryna Singh, Justin Moyers, Kristopher Wentzel, Navid Hafez, Vi K. Chiu

Age Group

Adult

Phase

IRB Number

STUDY00002835

ClinicalTrials.gov ID

NCT05990920

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

Name

Saba Mukarram

Phone

+1 310-231-2181

MukarramS@cshs.org