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NCT04410900 · ClinicalTrials.gov registry record · Phase 1
Vaccine Responsiveness After CAR-T Cell Therapy
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT04410900: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT04410900 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04410900, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
This phase I trial will use the inactivated rabies virus vaccine to assess immune function in patients who previously underwent B cell targeted chimeric antigen receptor-modified T cell immunotherapy (CARTx). A cohort of healthy volunteers will also be enrolled as a comparator group. CARTx is a new treatment for patients with B-cell malignancies (cancer of the B-cells), and the long-term effects of CARTx on immune function are not yet well understood. Learning more about vaccine responsiveness in patients who previously underwent CARTx may help doctors better understand immune function. The findings will guide evidence-based strategies for infection prevention to improve outcomes in this rapidly growing population of high-risk individuals.
Primary Outcome
This will be defined as a rabies virus neutralizing antibody (RVNA) titer ≥0.5 IU/ml at week 4 post-secondary immunization. This RVNA titer is considered to be evidence of an adequate immune response by the World Health Organization. Will estimate with 95% confidence intervals.
Interventions
- PROCEDURE Biospecimen Collection
- BIOLOGICAL Wistar Rabies Virus Strain PM-1503-3M Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2020-08-03 |
| Est. Completion | 2025-08-31 |
| Phase | Phase 1 |
What the finished NCT04410900 record still lists
NCT04410900 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Biospecimen Collection is the first listed.
NCT04410900 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04410900 about?
NCT04410900 is a clinical study titled "Vaccine Responsiveness After CAR-T Cell Therapy". This phase I trial will use the inactivated rabies virus vaccine to assess immune function in patients who previously underwent B cell targeted chimeric antigen receptor-modified T cell immunotherapy (CARTx). A cohort of healthy volunteers will also be enrolled as a comparator group. CARTx is a new ...
What is the current status of trial NCT04410900?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2020-08-03. Estimated completion is 2025-08-31.
What interventions are being tested in trial NCT04410900?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Wistar Rabies Virus Strain PM-1503-3M Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04410900?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04410900's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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