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Trial record 1 of 2 for:    NKmax
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Autologous Natural Killer Cells in Participants With Pathologically Confirmed Cancer

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. Identifier: NCT03941262
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : August 15, 2019
Information provided by (Responsible Party):
NKMax America, Inc.

Brief Summary:
This is a non-randomized, dose escalating and open-labeled clinical trial to evaluate the safety of autologous natural killer cell (NK) infusions (IV) of "SNK01" in participants with pathologically confirmed cancer refractory to conventional therapy . The primary objective of this study is to investigate the safety and tolerability of five infusions of "SNK01" in subjects with pathologically confirmed cancer refractory to conventional therapy . Secondary objective is preliminary efficacy of "SNK01" in participants with pathologically confirmed cancer refractory to conventional therapy .

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Drug: autologous natural killer cells Phase 1

Detailed Description:
Nine (9) participants, male or female, aged 18 years or older will be enrolled in the study, all of whom will receive "SNK01" without placebo control. There are three (3) subjects in each of the three (3) cohorts. The SNK01 study product will be administered at the following doses using dose escalating rules: Cohort 1 will receive 1 billion cells, Cohort 2 will receive 2 billion cells, and Cohort 3 will receive 4 billion cells. Length of participation, per participant, is approximately 9 weeks. The primary endpoint is safety: incidence and severity of dose-limiting toxicities (DLT's), adverse events, vital signs, physical examination, and clinical laboratory tests. The secondary endpoint is preliminary efficacy defined by objective response rate (ORR): the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Sequential Assignment
Intervention Model Description:

Non-randomized, open label, single center trial. Participants will receive SNK01 using a 3 + 3 dose escalating design:

Low dose - 1.0 x 10^9 cells Medium dose - 2.0 x 10^9 cells High dose - 4.0 x 10^9 cells

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 Participants With Pathologically Confirmed Cancer Refractory to Conventional Therapy
Actual Study Start Date : July 15, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: SNK01
Autologous natural killer cells (SNK01) administered IV once a week for five weeks
Drug: autologous natural killer cells
Biological: SNK01
Other Name: SNK01

Primary Outcome Measures :
  1. 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, )

  2. 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

Secondary Outcome Measures :
  1. 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

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.

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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

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 is 1.7 - 8.0 x 10^9/L
    • Platelet Count > 75 x 10^9/L
    • Hemoglobin for men is 13.5 to 17.5 g/dL; for women is 12.0 to 15.5.g/dL
    • No ongoing transfusion requirements
  • Adequate hepatic function:

    • Serum total bilirubin < 20 umol/L
    • Serum albumin ≥ 3.0 g/dL
    • ALT < 50 U/L and AST < 40 U/L
    • INR within normal limits (INR < 1.7)
    • 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 ( Examples include checkpoint inhibitors, adoptive cell transfer, monoclonal antibodies, treatment vaccines, cytokines, BCG, CAR-T therapy, and natural killer (NK) cell therapy.
  • Patients tested positive for hepatitis B and/or C surface antigen.
  • High fever or any active or unresolved infection, including 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 (LAR)

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 identifier (NCT number): NCT03941262

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Contact: Victoria S Chua-Alcala, MD (310)552-9999
Contact: Katherine JH Kim, MD (310)552-9999

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United States, California
Sarcoma Oncology Research Center, LLC Recruiting
Santa Monica, California, United States, 90403
Sponsors and Collaborators
NKMax America, Inc.
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Principal Investigator: Sant P Chawla, MD Sarcoma Oncology Research Center, LLC
Study Chair: Paul Y Song, MD NKMax America
Study Director: Pearl M Fang, PhD NKMax America
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Responsible Party: NKMax America, Inc. Identifier: NCT03941262    
Other Study ID Numbers: SNK01-US01
First Posted: May 7, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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