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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy

Clinicaltrials.gov identifier NCT03941262

Recruitment Status Recruiting

First Posted May 7, 2019

Last update posted May 3, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:Refractory Cancer
    Metastatic Cancer
    Recurrent Cancer
    Unresectable Carcinoma
    Solid Tumor, Adult
    Advanced Cancer
    Advanced Solid Tumor
  • Intervention/Treatment: Biological: SNK01
    Drug: Avelumab
    Drug: Pembrolizumab
  • Phase: Phase 1
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 27 participants
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: August 2021
  • Estimated Study Completion Date: December 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Cohort 1 - Low dose SNK01
SNK01 (low dose) administered once a week for five weeks.
Biological: SNK01
Patient-specific ex vivo expanded autologous natural killer cells
Experimental: Cohort 2 - Medium dose SNK01
SNK01 (medium dose) administered once a week for five weeks.
Biological: SNK01
Patient-specific ex vivo expanded autologous natural killer cells
Experimental: Cohort 3 - High dose SNK01
SNK01 (high dose) administered once a week for five weeks.
Biological: SNK01
Patient-specific ex vivo expanded autologous natural killer cells
Experimental: Cohort 4 - SNK01 with avelumab
SNK01 (high dose) administered in combination with avelumab once every two weeks (14-day cycle) for five cycles.
Biological: SNK01
Patient-specific ex vivo expanded autologous natural killer cells

Drug: Avelumab
Avelumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death-ligand 1 (PD-L1).
Experimental: Cohort 4 - SNK01 with pembrolizumab
SNK01 (high dose) administered in combination with pembrolizumab once every three weeks (21-day cycle) for five cycles.
Biological: SNK01
Patient-specific ex vivo expanded autologous natural killer cells

Drug: Pembrolizumab
Pembrolizumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death receptor-1 (PD-1).
Outcome Measures
  • Primary Outcome Measures: 1. To assess the safety profile [ Time Frame: Up to 6 months ]
    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.
  • Secondary Outcome Measures: 1. To assess clinical objective response rate (ORR) of SNK01 in patients with refractory cancer [ Time Frame: Up to 12 months ]
    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.
  • 2. To assess clinical objective response rate (ORR) of SNK01 in combination with avelumab in patients with refractory cancer [ Time Frame: Up to 12 months ]
    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.
  • 3. To assess clinical objective response rate (ORR) of SNK01 in combination with pembrolizumab in patients with refractory cancer [ Time Frame: Up to 12 months ]
    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.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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.

Contacts and Locations
Contacts

Contact: NKGen Biotech, Inc. 949-396-6830 trials@nkgenbiotech.com

Locations

United States, California
Sarcoma Oncology Research Center
Santa Monica

Sponsors and Collaborators

NKGen Biotech, Inc.

Investigators

Study Director: Steven S. Cha, MD NKGen Biotech, Inc.

More Information
  • Responsible Party: NKGen Biotech, Inc.
  • ClinicalTrials.gov Identifier: NCT03941262 History of Changes
  • Other Study ID Numbers: SNK01-US01
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 3, 2021
  • Last Verified: April 2021
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by NKGen Biotech, Inc.: Natural killer cell
    NK cell
    Expanded natural killer cell
    Immunotherapy
    Cancer
    Metastatic cancer
    Advanced solid tumor
    Refractory cancer
    Recurrent cancer
    Unresectable carcinoma
    Solid tumor
    Neoplasms
  • Additional relevant MeSH terms: Neoplasms
    Neoplasm Metastasis
    Recurrence