Advanced Solid Tumor Clinical Trial
Official title:
Phase 1, Open-Label, Safety Study of Escalating Doses of Ex Vivo Expanded, Autologous Natural Killer Cells in Patients With Pathologically Confirmed Cancer Refractory to Conventional Therapy
Verified date | July 2023 |
Source | NKGen Biotech, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of the study is to evaluate the safety and preliminary efficacy of SNK01 (autologous natural killer cell), as a single agent and in combination with avelumab or pembrolizumab, for the treatment of subjects with advanced and/or metastatic refractory cancer that has failed three or more prior lines of conventional standard of care therapy.
Status | Completed |
Enrollment | 27 |
Est. completion date | February 17, 2023 |
Est. primary completion date | February 17, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Voluntary written informed consent signed by patient, obtained prior to study enrollment. - Males and females ages 18 to 75 years, inclusive. - Pathologically confirmed diagnosis of refractory cancer that has failed three or more prior lines 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 <2. - At least 4 weeks since any prior systemic therapy (excluding corticosteroid therapy) to treat the underlying malignancy (standard or investigational). - At least 2 weeks since prior palliative radiotherapy. - Adequate bone marrow function: - Neutrophils: 2.0-8.0 K/uL - Platelet Count: 140-440 K/uL - Hemoglobin: 10.0-18.0 g/dL - No ongoing transfusion requirements - Adequate hepatic function: - Serum total bilirubin < 1.5 x upper limit of normal (ULN) - Serum albumin = 3.0 g/dL - Alanine transaminase (ALT) and aspartate transaminase (AST) = 2.5 x ULN - International normalized ratio (INR) = 1.5 x ULN - Adequate renal function with creatinine = 2.0 mg/dL. - Negative pregnancy test for women of childbearing potential and use of effective contraception (hormonal or barrier method of birth control) during study. 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 (example: checkpoint inhibitors, adoptive cell transfer, monoclonal antibodies, treatment vaccines, cytokines, Bacillus Calmette-Guerin (BCG), chimeric antigen receptor T cell therapy (CAR-T), and natural killer cell therapy). - Patients tested positive for hepatitis B and/or C surface antigen. - High fever or any active or unresolved infection, including human immunodeficiency virus (HIV) positive. - Autoimmune disease requiring therapy; immunodeficiency, or any disease process requiring immunosuppressive therapy. - Prior clinical trial requiring patient to receive an investigational drug within two weeks of enrollment. - Congestive heart failure, unstable angina or other underlying cardiac disease; history of thrombosis currently requiring anticoagulation. - Mental or psychological illness preventing cooperation with treatment, efficacy evaluations, or unable to understand the informed consent process. - Subjects who have undergone prior organ transplantation, including allogeneic stem-cell transplantation. - Adult subjects who lack capacity to consent for themselves and for whom consent must be provided by a legally authorized representative. - For SNK01+avelumab arm only: Subjects with prior hypersensitivity to avelumab or its excipients, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v4.03 Grade = 3). - For SNK01+avelumab arm only: Subjects with a significant immune-mediated adverse event due to a prior checkpoint inhibitor immunotherapy that led to permanent discontinuation of the therapy. |
Country | Name | City | State |
---|---|---|---|
United States | Sarcoma Oncology Research Center | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
NKGen Biotech, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the safety profile | Assessed by the incidence and severity of dose limiting toxicity (DLT) and other adverse events graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (NCI-CTCAE), Version 5.0, or the cytokine release syndrome revised grading system. | Up to 6 months | |
Secondary | To assess clinical objective response rate (ORR) of SNK01 in patients with refractory cancer | Objective response rate (ORR) is defined by the percentage of subjects who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. | Up to 12 months | |
Secondary | To assess clinical objective response rate (ORR) of SNK01 in combination with avelumab in patients with refractory cancer | Objective response rate (ORR) is defined by the percentage of subjects who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. | Up to 12 months | |
Secondary | To assess clinical objective response rate (ORR) of SNK01 in combination with pembrolizumab in patients with refractory cancer | Objective response rate (ORR) is defined by the percentage of subjects who achieve a confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1. | Up to 12 months |
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