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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03941262
Recruitment Status : Active, not recruiting
First Posted : May 7, 2019
Last Update Posted : March 15, 2023
Sponsor:
Information provided by (Responsible Party):
NKGen Biotech, Inc.

Study Description
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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 Intervention/treatment Phase
Refractory Cancer Metastatic Cancer Recurrent Cancer Unresectable Carcinoma Solid Tumor, Adult Advanced Cancer Advanced Solid Tumor Biological: SNK01 Drug: Avelumab Drug: Pembrolizumab Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
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 15, 2019
Actual Primary Completion Date : February 17, 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).
Other Name: Bavencio
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).
Other Name: Keytruda


Outcome Measures
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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
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941262


Locations
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United States, California
Sarcoma Oncology Research Center
Santa Monica, California, United States, 90403
Sponsors and Collaborators
NKGen Biotech, Inc.
Investigators
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Study Director: Paul Chang, MPH NKGen Biotech, Inc.
More Information
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Responsible Party: NKGen Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03941262    
Other Study ID Numbers: SNK01-US01
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023

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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:
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Neoplasms
Neoplasm Metastasis
Recurrence
Neoplastic Processes
Pathologic Processes
Disease Attributes
 Pembrolizumab
Avelumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action