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 ≥ 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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
SNK01 administered using an intravenous line (IV) to all patients at weeks 1, 2, 3, and 4
Hospital Angeles
Tijuana, Estado de Baja California, Mexico
The primary endpoint for safety is the dose-limiting toxicity (DLT)
DLT is a TEAE of grade ≥3 considered related to SNK01
Time frame: From enrollment to end of treatment at 8 Weeks
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.
Time frame: 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.
Time frame: 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 \[NCI-CTCAE v 5.0\]),
Time frame: From enrollment to end of treatment at 8 Weeks
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