Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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 : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
NKMax America, Inc.

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

Layout table for study information
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
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.
  • Patients with central nervous system (CNS) metastasis amenable to stereotactic surgery and/or uncontrolled primary brain tumors.
  • 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.
  • Adult subjects who lack capacity to consent for themselves and for whom consent must be provided by a legally authorized representative.

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


Contacts
Layout table for location contacts
Contact: NKMax America, Inc. 949-396-6830 trials@nkmaxamerica.com

Locations
Layout table for location information
United States, California
Sarcoma Oncology Research Center Recruiting
Santa Monica, California, United States, 90403
Contact: Victoria S. Chua-Alcala, MD, CLS    310-552-9999    vchua@sarcomaoncology.com   
Sponsors and Collaborators
NKMax America, Inc.
Investigators
Layout table for investigator information
Study Director: Paul Y. Song, MD NKMax America, Inc.
Layout table for additonal information
Responsible Party: NKMax America, Inc.
ClinicalTrials.gov Identifier: NCT03941262    
Other Study ID Numbers: SNK01-US01
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NKMax America, 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:
Layout table for MeSH terms
Neoplasm Metastasis
Recurrence
Neoplasms
Neoplastic Processes
Pathologic Processes
Disease Attributes
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents