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NCT04713046 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Allogeneic HPV-specific T Cells in Adults With Recurrent or Metastatic HPV16+ Cancers
A Phase 1 study of HPV 16+ Recurrent or Metastatic Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04713046: Recruiting Phase 1 study of HPV 16+ Recurrent or Metastatic Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT04713046 is a Phase 1 study of HPV 16+ Recurrent or Metastatic Cancer that is actively recruiting participants, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04713046, a Phase 1 study of HPV 16+ Recurrent or Metastatic Cancer, is actively recruiting participants, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, haploidentical relatives of a patient with recurrent or metastatic HPV 16-associated malignancy will be vaccinated with a therapeutic human papillomavirus (HPV) vaccine series to generate HPV-specific leukocytes. The cancer patient with recurrent or metastatic HPV16+ cancer will then be randomized to one of two arms: 1) non-myeloablative allogeneic bone marrow transplant or 2) cluster of differentiation 8 (CD8)-depleted donor lymphocyte infusion.
Primary Outcome
Determine the safety of the two interventions in patients with recurrent or metastatic HPV16-associated cancer. Safety will be monitored for every patient and we will document and grade every adverse event using the NCI CTCAE version 5.0.
Conditions Studied
Interventions
- BIOLOGICAL CD8 reduced peripheral blood cells taken from related donors vaccinated against HPV16
- BIOLOGICAL Non-myeloablative allogeneic bone marrow transplant from related donors vaccinated against HPV16
Study Locations (1)
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-10-18 |
| Est. Completion | 2026-10-01 |
| Phase | Phase 1 |
What NCT04713046 shows while recruiting
NCT04713046 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 1 condition, with HPV 16+ Recurrent or Metastatic Cancer appearing as the primary indexed condition, and to 2 interventions - of which CD8 reduced peripheral blood cells taken from related donors vaccinated against HPV16 is the first listed.
NCT04713046 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04713046 about?
NCT04713046 is a clinical study titled "Safety and Efficacy of Allogeneic HPV-specific T Cells in Adults With Recurrent or Metastatic HPV16+ Cancers". In this study, haploidentical relatives of a patient with recurrent or metastatic HPV 16-associated malignancy will be vaccinated with a therapeutic human papillomavirus (HPV) vaccine series to generate HPV-specific leukocytes. The cancer patient with recurrent or metastatic HPV16+ cancer will then ...
What is the current status of trial NCT04713046?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-10-18. Estimated completion is 2026-10-01.
What conditions does trial NCT04713046 study?
This clinical trial studies the following conditions: HPV 16+ Recurrent or Metastatic Cancer.
What interventions are being tested in trial NCT04713046?
The interventions under investigation include: CD8 reduced peripheral blood cells taken from related donors vaccinated against HPV16 (BIOLOGICAL), Non-myeloablative allogeneic bone marrow transplant from related donors vaccinated against HPV16 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04713046?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04713046 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04713046's enrollment target sits among peer trials
24 1521st of 2000 higher than 405 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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