Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03941262
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : November 9, 2021
Sponsor:
Information provided by (Responsible Party):
NKGen Biotech, Inc.

Tracking Information
First Submitted Date  ICMJE May 3, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date November 9, 2021
Actual Study Start Date  ICMJE July 15, 2019
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Safety Measure: Adverse Events [ Time Frame: From enrollment to end of treatment at nine weeks] ]
    Frequency and type of adverse events, assessed using NCI-CTCAE v 5.0, )
  • Safety Measure: Cytokine Release Syndrome (CRS) [ Time Frame: From enrollment to end of treatment at nine weeks ]
    CRS revised grading system (Lee et al., Blood 2014 July 10; 124(2) 188-95
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2020)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
Preliminary Efficacy Measure: Objective Response [ Time Frame: From enrollment to end of treatment at nine weeks ]
Percentage of participants with objective response, either complete response or partial response, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and iRECIST
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of SNK01 in Subjects With Pathologically Confirmed Metastatic and/or Unresectable Cancer Refractory to Conventional Therapy
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Refractory Cancer
  • Metastatic Cancer
  • Recurrent Cancer
  • Unresectable Carcinoma
  • Solid Tumor, Adult
  • Advanced Cancer
  • Advanced Solid Tumor
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Cohort 1 - Low dose SNK01
    SNK01 (low dose) administered once a week for five weeks.
    Intervention: Biological: SNK01
  • Experimental: Cohort 2 - Medium dose SNK01
    SNK01 (medium dose) administered once a week for five weeks.
    Intervention: Biological: SNK01
  • Experimental: Cohort 3 - High dose SNK01
    SNK01 (high dose) administered once a week for five weeks.
    Intervention: Biological: SNK01
  • Experimental: Cohort 4 - SNK01 with avelumab
    SNK01 (high dose) administered in combination with avelumab once every two weeks (14-day cycle) for five cycles.
    Interventions:
    • Biological: SNK01
    • Drug: Avelumab
  • Experimental: Cohort 4 - SNK01 with pembrolizumab
    SNK01 (high dose) administered in combination with pembrolizumab once every three weeks (21-day cycle) for five cycles.
    Interventions:
    • Biological: SNK01
    • Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 18, 2020)
27
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2019)
9
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date August 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: NKGen Biotech, Inc. 949-396-6830 trials@nkgenbiotech.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941262
Other Study ID Numbers  ICMJE SNK01-US01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NKGen Biotech, Inc.
Study Sponsor  ICMJE NKGen Biotech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steven S. Cha, MD NKGen Biotech, Inc.
PRS Account NKGen Biotech, Inc.
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP