- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04363346
Study of FT516 for the Treatment of COVID-19 in Hospitalized Patients With Hypoxia
Study of FT516 Safety and Feasibility for the Treatment of Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients With Hypoxia
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay.
Requires hospitalization and meets the following:
- Radiographic infiltrates by imaging (chest x-ray, CT scan)
- Able to maintain Sp02 ≥ 93% oxygen supplementation to a maximum 4L by low flow O2-delivery device at rest
- IL-6 level ≥40 pg/ml but <150 pg/mL OR CRP ≥40 mg/L (4 mg/dL) but <150 mg/L (15 mg/dL)
- Ferritin < 1000 ng/mL
- HCT-CI score of 4 or less - For this score, if PFTs results are not available, any patient requiring oxygen prior to COVID-19 illness is not eligible
- Report of usual daily activity level (before COVID-19 illness) of Karnofsky ≥70%
- ≥ 18 years of age, but < 76 years at time of consent signing
- Females of child-bearing potential and males with partners of child-bearing potential must agree to use highly effective contraception from the time of consent and for at least 3 months after the last dose of FT516
- Agrees to and signs the separate consent for up to 15 years of follow-up on a separate LTFU companion study (IDIM-2020-28770)
- Voluntary written consent prior to the performance of any research related procedures
Exclusion Criteria:
- Any medical condition or clinical laboratory abnormality that per Investigator judgement precludes safe participation in and completion of the study, or which could affect compliance with protocol conduct or interpretation of results.
- Need for higher-percentage oxygen delivery device (face mask, oxymizer, nonrebreather, venti-mask or pressure support with CPAP/BiPAP)
- Patients with adequate oxygenation on room air
- Receiving concomitant COVID-19 directed therapy (drugs may be stopped to make patients eligible)
- Known allergy to the following FT516 components: albumin (human) or DMSO
- Any known condition that requires systemic immunosuppressive therapy (> 5mg prednisone daily or equivalent) topical and inhale steroids are permitted
- Active autoimmune disease requiring systemic immunosuppressive therapy
- History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
- Known history of HIV positivity
- Pregnant or breast feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Strategy 1
Dose Strategy 1: Day 1 - FT516 is given at 9x107 cells/dose (low) |
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.
|
Experimental: Dose Strategy 2
Dose Strategy 2: Day 1 - FT516 is given at 9x107 cells/dose (low) + Day 4 - FT516 is given at 3x108 cells/dose (mid) |
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.
|
Experimental: Dose Strategy 3
Dose Strategy 3: Day 1 - FT516 is given at 9x107 cells/dose (low) + Day 4 - FT516 is given at 3x108 cells/dose (mid) + Day 7 - FT516 is given at 9x108 cells/dose (high) |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with Dose Limiting Toxicity Events
Time Frame: within 7 days after the last dose of FT516
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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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within 7 days after the last dose of FT516
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The time in days from the 1st FT516 infusion to the elimination of viral shedding in nasal pharyngeal and stool samples
Time Frame: 36 days
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36 days
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The time in days from the 1st FT516 infusion to discontinued need for supplemental oxygen
Time Frame: 36 Days
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36 Days
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The time in days from the 1st FT516 infusion to hospital discharge
Time Frame: 36 Days
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36 Days
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Collaborators and Investigators
Investigators
- Principal Investigator: Dr.Joshua Rhein, MD, Department of Medicine, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IDIM-2020-28708
- 2020LS083 (Other Identifier: University of Minnesota Masonic Cancer Center)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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