Autologous Natural Killer Cells in Subjects With Plaque Psoriasis

NCT03894579 | Completed Phase 1 FDA Drug

• 1 other identifier: SNK01-MX03
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Plaque Psoriasis

Keywords

natural killer cells; autologous

Outcome Measures

Primary Outcomes (1)

• The primary endpoint for safety is the dose-limiting toxicity (DLT)

  DLT is a TEAE of grade ≥3 considered related to SNK01

  From enrollment to end of treatment at 8 Weeks

Secondary Outcomes (3)

• Preliminary Efficacy by Physician Global Assessment (PGA)

  From enrollment to end of treatment at 8 Weeks

• Preliminary Efficacy by Psoriasis Area and Severity Index (PASI)

  From enrollment to end of treatment at 8 Weeks

• Secondary Safety Measures: Other Non-DLT Adverse Events

  From enrollment to end of treatment at 8 Weeks

Study Arms (1)

SNK01

EXPERIMENTAL

SNK01 infused weekly for 4 consecutive weeks

Biological: Study Product: SNK01

Interventions

Study Product: SNK01 BIOLOGICAL

SNK01 administered using an intravenous line (IV) to all patients at weeks 1, 2, 3, and 4

SNK01

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• 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:
• Condoms, sponge, foams, jellies, diaphragm, or intrauterine device (IUD)
• Hormonal contraceptives for 90 days prior to study drug administration
• A vasectomized partner
• Subject must be able and willing to provide written informed consent and comply with requirements of this study protocol
• Following Eligibility \& Consent:
• 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
• Successful establishment of the final NK product, or "study therapy", established by NKMax America

You may not qualify if:

• Subjects who fulfill any of the following criteria will not be recruited into the study:
• Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study
• Subject has Netherton's syndrome or other genodermatoses that results in a defective epidermal barrier
• 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
• 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
• 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
• 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
• Subjects receiving phototherapy (e.g., ultraviolet light B \[UVB\], psoralen plus ultraviolet light A \[PUVA\]) within 28 days of the baseline visit.
• 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.
• 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)
• Subjects with an active bacterial, viral or fungal skin infection (excluding nail fungus)
• Ongoing participation in an investigational drug trial
• Presence of psoriasis with exfoliative erythroderma or presence of guttate psoriasis, primary palmoplantar psoriasis, or pustular psoriasis

Sponsors & Collaborators

• NKGen Biotech, Inc.: lead

Study Sites (1)

Hospital Angeles

Tijuana, Estado de Baja California, 22010, Mexico

Location

Study Officials

• Daniela Gutiérrez, MD

  Hospital Angeles Tijuana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: open-label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 6, 2019
• First Posted: March 28, 2019
• Study Start: July 18, 2019
• Primary Completion: December 3, 2019
• Study Completion: December 3, 2019
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

ME (1)