Status:
COMPLETED
Study of FT516 for the Treatment of COVID-19 in Hospitalized Patients With Hypoxia
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
COVID-19
Eligibility:
All Genders
18-76 years
Phase:
PHASE1
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 coro...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04363346
Start Date
May 14 2020
End Date
February 18 2021
Last Update
April 5 2022
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455