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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 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. The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04713046
The ClinicalTrials.gov registry entry for NCT04713046 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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