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NCT04363346 · ClinicalTrials.gov registry record · Phase 1
Study of FT516 for the Treatment of COVID-19 in Hospitalized Patients With Hypoxia
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT04363346: Completed Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT04363346 is a Phase 1 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04363346, a Phase 1 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study 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.
Primary Outcome
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: * Grade 3 or greater infusion related reaction following FT516 infusion * Any new or worsening Grade 3 and any Grade 4 adverse events with the exception of the following known complications of COVID-19: * Grade 3 gast
Interventions
- DRUG FT516
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-05-14 |
| Est. Completion | 2021-02-18 |
| Phase | Phase 1 |
What the finished NCT04363346 record still lists
NCT04363346 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which FT516 is the first listed.
NCT04363346 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04363346 about?
NCT04363346 is a clinical study titled "Study of FT516 for the Treatment of COVID-19 in Hospitalized Patients With Hypoxia". 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 ...
What is the current status of trial NCT04363346?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2020-05-14. Estimated completion is 2021-02-18.
What interventions are being tested in trial NCT04363346?
The interventions under investigation include: FT516 (DRUG).
Who is sponsoring clinical trial NCT04363346?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04363346's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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