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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.
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 ā„ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNK01 | Experimental | SNK01 infused weekly for 4 consecutive weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Study Product: SNK01 | Biological | SNK01 administered using an intravenous line (IV) to all patients at weeks 1, 2, 3, and 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint for safety is the dose-limiting toxicity (DLT) | DLT is a TEAE of grade ā„3 considered related to SNK01 | From enrollment to end of treatment at 8 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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
Exclusion Criteria:
Subjects who fulfill any of the following criteria will not be recruited into the study:
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| Name | Affiliation | Role |
|---|---|---|
| Daniela GutiƩrrez, MD | Hospital Angeles Tijuana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Angeles | Tijuana | Estado de Baja California | 22010 | Mexico |
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Non-randomized, open label, single center trial. Subjects will receive SNK01 using a 3 + 3 dose escalating design
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open-label
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| From enrollment to end of treatment at 8 Weeks |
| 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. | From enrollment to end of treatment at 8 Weeks |
| 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]), | From enrollment to end of treatment at 8 Weeks |