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NCT04401410 · ClinicalTrials.gov registry record · Phase 1
Anti-SARS Cov-2 T Cell Infusions for COVID 19
A Phase 1 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT04401410: Clinical Trial Phase 1 study, sponsored by Baylor College of Medicine.
NCT04401410 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. 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
NCT04401410, a Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation. The SARS-CoVSTs lines have been made at Baylor College of Medicine from healthy donors who have made a full recovery from COVID19. These cell lines were frozen for later use and will be thawed and used to treat patients who meet the eligibility criteria.
Primary Outcome
Defined as the proportion of subjects with toxicity including the type, severity, time of onset, time of resolution, and the probable association with study treatment. A dose limiting toxicity is defined as any acute GvHD (\> grade 2), grade ≥3 CRS or ICANS, grade ≥3 hematologic toxicity or grade ≥3 non-hematologic adverse events related to the T cell product within 14 days of the VST infusion and that are not due to pre-existing conditions as defined by the NCI Common Terminology Criteria for A
Interventions
- BIOLOGICAL Dose Finding Phase (MTD)
- BIOLOGICAL Partially HLA-matched SARS-CoVSTs
- OTHER Routine care (no SARS-CoVSTs)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2020-11-04 |
| Est. Completion | 2021-10-12 |
| Phase | Phase 1 |
Why NCT04401410 stopped before completion
NCT04401410 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 3 interventions - of which Dose Finding Phase (MTD) is the first listed.
NCT04401410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04401410 about?
NCT04401410 is a clinical study titled "Anti-SARS Cov-2 T Cell Infusions for COVID 19". This is a dose-finding safety trial followed by a randomized pilot trial comparing administration of SARS-CoV2-specific T cells (SARS-CoVSTs) to standard of care treatment in hospitalized patients with COVID19 who are at high risk of requiring mechanical ventilation. The SARS-CoVSTs lines have been...
What is the current status of trial NCT04401410?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2020-11-04. Estimated completion is 2021-10-12.
What interventions are being tested in trial NCT04401410?
The interventions under investigation include: Dose Finding Phase (MTD) (BIOLOGICAL), Partially HLA-matched SARS-CoVSTs (BIOLOGICAL), Routine care (no SARS-CoVSTs) (OTHER).
Who is sponsoring clinical trial NCT04401410?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04401410'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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