Autologous Natural Killer Cells in Subjects With Plaque Psoriasis
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ClinicalTrials.gov Identifier: NCT03894579 |
Recruitment Status :
Completed
First Posted : March 28, 2019
Last Update Posted : June 26, 2020
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Tracking Information | |||||||
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First Submitted Date ICMJE | March 6, 2019 | ||||||
First Posted Date ICMJE | March 28, 2019 | ||||||
Last Update Posted Date | June 26, 2020 | ||||||
Actual Study Start Date ICMJE | July 18, 2019 | ||||||
Actual Primary Completion Date | December 3, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 | Allocation: N/A 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
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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
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Study Arms ICMJE | Experimental: SNK01
SNK01 infused weekly for 4 consecutive weeks
Intervention: Biological: Study Product: SNK01
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
9 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date ICMJE | December 3, 2019 | ||||||
Actual Primary Completion Date | December 3, 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:
Exclusion Criteria: Subjects who fulfill any of the following criteria will not be recruited into the study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
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 |
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IPD Sharing Statement ICMJE | Not Provided | ||||||
Responsible Party | NKGen Biotech, Inc. | ||||||
Study Sponsor ICMJE | NKGen Biotech, Inc. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | NKGen Biotech, Inc. | ||||||
Verification Date | June 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |