Study of FT516 for the Treatment of COVID-19 in Hospitalized Patients With Hypoxia
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ClinicalTrials.gov Identifier: NCT04363346 |
Recruitment Status :
Completed
First Posted : April 27, 2020
Last Update Posted : April 5, 2022
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Tracking Information | |||||
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First Submitted Date ICMJE | April 23, 2020 | ||||
First Posted Date ICMJE | April 27, 2020 | ||||
Last Update Posted Date | April 5, 2022 | ||||
Actual Study Start Date ICMJE | May 14, 2020 | ||||
Actual Primary Completion Date | February 18, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of participants with Dose Limiting Toxicity Events [ Time Frame: within 7 days after the last dose of FT516 ] An accelerated (fast-track) design will continue until first DLT is observed or the maximum Tolerated Dose (MTD) is determined.
DLT is defined as any treatment emergent toxicity within 7 days after the last dose of FT516 meeting one of the following criteria based on CTCAE v5:
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study of FT516 for the Treatment of COVID-19 in Hospitalized Patients With Hypoxia | ||||
Official Title ICMJE | Study of FT516 Safety and Feasibility for the Treatment of Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients With Hypoxia | ||||
Brief Summary | This is a Phase I study with the primary objective of identifying the maximum tolerated dose (MTD) of FT516 using 3 dose-escalation strategies (number of doses and cell dose) for the treatment of coronavirus disease 2019 (COVID-19). This study provides initial estimates of safety and efficacy based on stable respiratory function, as well as, determining the feasibility for full-scale studies designed both for efficacy and safety. | ||||
Detailed Description | Given the urgency of COVID-19 and the known anti-viral activity of natural killer (NK) cells, this clinical trial uses immediately available off-the-shelf induced pluripotent stem cell (iPSC) derived NK cells already being used to treat cancer patients. FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation. The investigators expect that natural developing anti-COVID IgG (early data suggest that some develop in 7-10 days after diagnosis) will enhance targeting of FT516 to infected cells. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Intervention Model Description: The study starts with a fast-track design by proceeding in cohorts of one patient until the first DLT is observed. If no DLT is observed, escalation continues by one patient per cohort until Dose Strategy 3 is reached. If the MTD is not yet established by Dose Strategy 3, Dose Strategy 3 is expanded to 6 patients using the final stage of a "3+3" design. An extension of 4 additional patients is planned if FT516 continues to be safe for a total of 10 patients treated at the MTD. Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | COVID-19 | ||||
Intervention ICMJE | Drug: FT516
FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation.
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Study Arms ICMJE |
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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 |
5 | ||||
Original Estimated Enrollment ICMJE |
12 | ||||
Actual Study Completion Date ICMJE | February 18, 2021 | ||||
Actual Primary Completion Date | February 18, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 76 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04363346 | ||||
Other Study ID Numbers ICMJE | IDIM-2020-28708 2020LS083 ( Other Identifier: University of Minnesota Masonic Cancer Center ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Masonic Cancer Center, University of Minnesota | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Masonic Cancer Center, University of Minnesota | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Masonic Cancer Center, University of Minnesota | ||||
Verification Date | April 2022 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |