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NCT04397796 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation
A Phase 1 study, sponsored by ImmunityBio.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT04397796: Clinical Trial Phase 1 study, sponsored by ImmunityBio.
NCT04397796 is a Phase 1 study that was terminated before completion, run by ImmunityBio. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04397796, a Phase 1 study, was terminated before completion, sponsored by ImmunityBio.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a phase 1b randomized, double-blind, placebo-controlled study in adult subjects with Coronavirus Disease 2019 (COVID-19). This clinical trial will evaluate the preliminary safety and efficacy of BM-Allo.MSC vs placebo in treating subjects with severe disease requiring ventilator support during COVID 19 infection.
Primary Outcome
Incidence of AEs within 30 days of randomization.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL BM-Allo.MSC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-08-03 |
| Est. Completion | 2020-09-06 |
| Phase | Phase 1 |
Why NCT04397796 stopped before completion
NCT04397796 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04397796 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04397796 about?
NCT04397796 is a clinical study titled "Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation". This is a phase 1b randomized, double-blind, placebo-controlled study in adult subjects with Coronavirus Disease 2019 (COVID-19). This clinical trial will evaluate the preliminary safety and efficacy of BM-Allo.MSC vs placebo in treating subjects with severe disease requiring ventilator support duri...
What is the current status of trial NCT04397796?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2020-08-03. Estimated completion is 2020-09-06.
What interventions are being tested in trial NCT04397796?
The interventions under investigation include: Placebo (BIOLOGICAL), BM-Allo.MSC (BIOLOGICAL).
Who is sponsoring clinical trial NCT04397796?
This trial is sponsored by ImmunityBio, which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04397796's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 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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