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Plaque PsoriasisPhase 1NCT03894579

Autologous Natural Killer Cells in Subjects With Plaque Psoriasis

A Phase 1 study testing Study Product: SNK01 in people with Plaque Psoriasis, run by NKGen Biotech, Inc. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Plaque Psoriasis
What is being tested?
Study Product: SNK01
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteMexico
Study dates
18 Jul 2019to 3 Dec 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Hospital Angeles

    Tijuana, Estado de Baja California, 22010

Other trials in Mexico

About this study

Official title: Phase 1, Open-Label, Safety Study of Escalating Doses of Ex Vivo Expanded, Autologous Natural Killer Cells in Subjects With Plaque Psoriasis

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.

Read the 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.

Being tested
Study Product: SNK01
Keywords
natural killer cells, autologous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Study Product: SNK01Biological

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

Study groups in NCT03894579
Study groupRoleWhat they receive
SNK01ExperimentalSNK01 infused weekly for 4 consecutive weeks
Receives: Biological: Study Product: SNK01

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: From enrollment to end of treatment at 8 Weeks

Secondary outcomes (3)

  1. Preliminary Efficacy by Physician Global Assessment (PGA)

    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.

    Measured: From enrollment to end of treatment at 8 Weeks

  2. Preliminary Efficacy by Psoriasis Area and Severity Index (PASI)

    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.

    Measured: From enrollment to end of treatment at 8 Weeks

  3. Secondary Safety Measures: Other Non-DLT Adverse Events

    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]),

    Measured: From enrollment to end of treatment at 8 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2019
  2. Study start18 Jul 2019
  3. Primary completion3 Dec 2019
  4. Study completion3 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Non-randomized, open label, single center trial. Subjects will receive SNK01 using a 3 + 3 dose escalating design
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03894579
Sponsor's protocol ID
SNK01-MX03
Status last verified
Jun 2020
First submitted
6 Mar 2019
Last updated
26 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Study Product: SNK01 in people with Plaque Psoriasis, run by NKGen Biotech, Inc. at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint for safety is the dose-limiting toxicity (DLT) (time frame: From enrollment to end of treatment at 8 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03894579.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.

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