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Autologous Natural Killer Cells in Subjects With Plaque Psoriasis

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: NCT03894579
Recruitment Status : Recruiting
First Posted : March 28, 2019
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
NKMax America, Inc.

Tracking Information
First Submitted Date  ICMJE March 6, 2019
First Posted Date  ICMJE March 28, 2019
Last Update Posted Date August 29, 2019
Actual Study Start Date  ICMJE July 24, 2019
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
The primary endpoint for safety is the dose-limiting toxicity (DLT) [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
DLT is a TEAE of grade ≥3 considered related to SNK01
Original Primary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
  • Safety Measures: Adverse Events [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    Frequency and type of adverse events, assessed using NCI-CTCAE v 5.0
  • Safety Measures: Physical Examinations [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    Complete physical examination at each study visit will include an assessment of head, eyes, ears, nose, and throat (HEENT), gastrointestinal (GI), cardiovascular, respiratory, integumentary, muscular-skeleton, and neurological systems; assess change from baseline to Week 8.
  • Safety Measures: Blood Pressure [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    change from baseline to Week 8
  • Safety Measures: Respiratory Rate [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    change from baseline to Week 8
  • Safety Measures: Pulse Rate [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    change from baseline to Week 8
  • Safety Measures: Weight [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    Weight measured in kilograms; assess change from baseline to Week 8
  • Safety Measures: Height [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    Height measured in meters; change from baseline to Week 8
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2019)
  • Preliminary Efficacy by Physician Global Assessment (PGA) [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    The Physician Global Assessment (PGA) is a 6-point scoring system used to assess disease severity at a given time point. The PGA is a six-point score that summarizes the overall quality (erythema, scaling and thickness) and extent of Psoriasis plaques where (0) is clear, (1) minimal, (2) mild, (3) moderate, (4) severe, and (5) being very severe psoriasis. Change in score from baseline through Week 8 will be assessed.
  • Preliminary Efficacy by Psoriasis Area and Severity Index (PASI) [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    Psoriasis Area and Severity Index (PASI) is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Change in score from baseline through Week 8 will be assessed.
  • Secondary Safety Measures: Other Non-DLT Adverse Events [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    Frequency and type of Non-DLT adverse events (graded according to National Cancer Institute's Common Toxicity Criteria for Adverse Events [NCI-CTCAE v 5.0]),
Original Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
  • Physician Global Assessment (PGA) [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    The Physician Global Assessment (PGA) is a 6-point scoring system used to assess disease severity at a given time point. The PGA is a six-point score that summarizes the overall quality (erythema, scaling and thickness) and extent of Psoriasis plaques where (0) is clear, (1) minimal, (2) mild, (3) moderate, (4) severe, and (5) being very severe psoriasis. Change in score from baseline through Week 8 will be assessed.
  • Psoriasis Area and Severity Index (PASI) [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    Psoriasis Area and Severity Index (PASI) is the most widely used tool for the measurement of severity of psoriasis. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). Change in score from baseline through Week 8 will be assessed.
  • Dermatology Life Quality Index (DLQI) [ Time Frame: From enrollment to end of treatment at 8 Weeks ]
    The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. The 10 questions cover the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life). Change in score from baseline through Week 8 will be assessed.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Natural Killer Cells in Subjects With Plaque Psoriasis
Official Title  ICMJE Phase 1, Open-Label, Safety Study of Escalating Doses of Ex Vivo Expanded, Autologous Natural Killer Cells in Subjects With Plaque Psoriasis
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 adults with plaque psoriasis. The primary objective of this study is to investigate the safety and tolerability of four infusions of "SNK01" in subjects with plaque psoriasis. Secondary objective is preliminary efficacy of "SNK01" in subjects with plaque psoriasis.
Detailed Description Nine (9) subjects, 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 4 weekly infusions of 1 billion cells, Cohort 2 will receive 4 weekly infusions of 2 billion cells, and Cohort 3 will receive 4 weekly infusions of 4 billion cells. Length of participation, per subject, is approximately 12 weeks. The primary endpoint for safety is dose-limiting toxicity (DLT) which is defined as TEAE of grade ≥ 3 considered related to SNK01. Secondary safety endpoints include other adverse events (graded according to National Cancer Institute's Common Toxicity Criteria for Adverse Events [NCI-CTCAE v 5.0]), vital sign measurements, clinical laboratory tests and physical examination. Preliminary efficacy will be measured by Psoriasis Area Severity Index (PASI) and by the Physician's Global Assessment (PGA.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Non-randomized, open label, single center trial. Subjects will receive SNK01 using a 3 + 3 dose escalating design
Masking: None (Open Label)
Masking Description:
open-label
Primary Purpose: Treatment
Condition  ICMJE Plaque Psoriasis
Intervention  ICMJE Biological: Study Product: SNK01
SNK01 administered using an intravenous line (IV) to all patients at weeks 1, 2, 3, and 4
Study Arms  ICMJE Experimental: SNK01
SNK01 infused weekly for 4 consecutive weeks
Intervention: Biological: Study Product: SNK01
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: March 26, 2019)
9
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 15, 2020
Estimated Primary Completion Date December 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects will be considered eligible for participation in the study if all the following inclusion criteria are satisfied:

  1. Informed consent obtained before any "trial-related activities" (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
  2. Diagnosis of plaque psoriasis for at least 6 months with at least one psoriatic plaque measuring between 2 cm and 5 cm at the time of screening
  3. If female, subject is either not of childbearing potential (postmenopausal for at least 1 year or surgically sterile) or is of childbearing potential and is using approved method of birth control throughout study and for 1 month after last dose of study drug. Approved methods of birth control include the following:

    1. Condoms, sponge, foams, jellies, diaphragm, or intrauterine device (IUD)
    2. Hormonal contraceptives for 90 days prior to study drug administration
    3. A vasectomized partner
  4. Subject must be able and willing to provide written informed consent and comply with requirements of this study protocol

    Following Eligibility & Consent:

  5. Subject must be able to donate 130 ml to 490 ml of blood for NKMax America to obtain an adequate number of autologous NK cells necessary to establish the final investigational product
  6. Successful establishment of the final NK product, or "study therapy", established by NKMax America

Exclusion Criteria:

Subjects who fulfill any of the following criteria will not be recruited into the study:

  1. Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  2. Subject has Netherton's syndrome or other genodermatoses that results in a defective epidermal barrier
  3. Subjects who have applied topical medication (prescription or over-the-counter) for the treatment of psoriasis to their body within 7 days of the baseline visit
  4. Subjects who have taken cyclosporine, methotrexate, immuran, oral retinoids, chemotherapeutic agents, anti-inflammatory biologics (e.g., alefacept, etanercept, etc.), or oral calcineurin inhibitors within 28 days of the whole blood donation visit for the establishment of the investigational product
  5. Subjects who are unable to hold their current psoriasis medications for the period of time indicated (at least 7 days for topical medications, at least 28 days for oral or injectable medications) without significant worsening of their psoriasis
  6. Immunocompromised subjects (e.g., lymphoma, HIV/AIDS, Wiskott-Aldrich Syndrome) or subjects with a history of malignant disease (excluding non-melanoma skin cancer) as determined by the participant's medical history
  7. Subjects receiving phototherapy (e.g., ultraviolet light B [UVB], psoralen plus ultraviolet light A [PUVA]) within 28 days of the baseline visit.
  8. Subjects with a history of psychiatric disease or history of alcohol or drug abuse that would interfere with the ability to comply with the study protocol.
  9. Subjects with significant concurrent medical condition(s) at screening that in the view of the investigator prohibits that in the view of the investigator prohibits participation in the study (e.g., severe concurrent allergic disease, condition associated with malignancy, and condition associated with immunosuppression)
  10. Subjects with an active bacterial, viral or fungal skin infection (excluding nail fungus)
  11. Ongoing participation in an investigational drug trial
  12. Presence of psoriasis with exfoliative erythroderma or presence of guttate psoriasis, primary palmoplantar psoriasis, or pustular psoriasis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Vanessa Teachout 619-301-1387 vteachout@nkmaxamerica.com
Contact: Michael Bayer 949-290-8404 mbayer@nkmaxamerica.com
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03894579
Other Study ID Numbers  ICMJE SNK01-MX03
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
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NKMax America, Inc.
Study Sponsor  ICMJE NKMax America, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Daniela Gutiérrez, MD Hospital Angeles Tijuana
PRS Account NKMax America, Inc.
Verification Date August 2019

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