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

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

NCT ID: NCT05990920

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

Conditions: Official terms:
Recurrence

Study type: Interventional

Study phase: Phase 1

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: SNK02
Description: SNK02 is ex vivo expanded allogeneic NK cells for IV injection, is a light-yellow cryopreserved cell suspension consisting of NK cells isolated from healthy donor's peripheral blood mononuclear cells.
Arm group label: Cohort 1

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.

Criteria for 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-fac t-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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Angeles Clinic and Research Institute

Address:
City: Los Angeles
Zip: 90025
Country: United States

Facility:
Name: Sarcoma Oncology Center

Address:
City: Santa Monica
Zip: 90403
Country: United States

Start date: August 23, 2023

Completion date: December 2024

Lead sponsor:
Agency: NKGen Biotech, Inc.
Agency class: Industry

Source: NKGen Biotech, Inc.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05990920