Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06508138
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
Clinical Trial Assessing the Safety and Immunologic Correlates of Heterologous Prime-Boost With pNGVL4a-SigE7DetoxHSP70 and TA-HPV in Healthy Donors Followed by Peripheral Blood Collection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Clinical Trial Assessing the Safety and Immunologic Correlates of Heterologous Prime-Boost With pNGVL4a-SigE7DetoxHSP70 and TA-HPV in Healthy Donors Followed by Peripheral Blood Collection
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
J21112LINKED
Brief Summary:
This healthy related donor clinical trial is linked to a recipient clinical trial protocol for therapeutic purposes In this healthy donor protocol haploidentical relatives of a patient with recurrent or metastatic human papilloma virus RM HPV 16-associated malignancy will be invited to be vaccinated with a therapeutic HPV vaccine series PVX1 to generate HPV-specific white blood cells In the linked recipient phase 1 clinical trial protocol patient with incurable locally recurrent or metastatic HPV 16-associated head and neck cancer will be randomized to one of two arms
Arm A non-myeloablative NMA allogeneic bone marrow transplant alloBMT OR Arm B CD8-depleted donor lymphocyte infusion DLI on Day 0 of a dose escalation scheme
These two clinical trials are separated so that the healthy donor trial deals exclusively with issues of safety and immunological efficacy of the HPV vaccine series and this companion recipient trial examines the safety feasibility and clinically efficacy of the allogeneic bone marrow graft and CD8-depleted DLI The central hypothesis of the clinical trial is that patients with RM HPV-associated malignancies can be safely and effectively treated by allogeneic bone marrow transplantation andor CD8-depleted DLI from a healthy related donor that has been vaccinated against HPV16 E6 and E7 proteins
Arm A non-myeloablative NMA allogeneic bone marrow transplant alloBMT OR Arm B CD8-depleted donor lymphocyte infusion DLI on Day 0 of a dose escalation scheme
These two clinical trials are separated so that the healthy donor trial deals exclusively with issues of safety and immunological efficacy of the HPV vaccine series and this companion recipient trial examines the safety feasibility and clinically efficacy of the allogeneic bone marrow graft and CD8-depleted DLI The central hypothesis of the clinical trial is that patients with RM HPV-associated malignancies can be safely and effectively treated by allogeneic bone marrow transplantation andor CD8-depleted DLI from a healthy related donor that has been vaccinated against HPV16 E6 and E7 proteins
Detailed Description:
Scientists have found that a family of viruses called the Human Papillomavirus HPV can cause certain cancers particularly in the head and neck and cervix Most of these cancers are caused by a specific type of HPV called HPV16 This research is being done to see if giving an investigational vaccine against HPV causes the participants immune system to respond against proteins that are made by the vaccine and by the cancer in the participants relative The investigators would like to see if cells of the immune system that have responded to the vaccine can be found in the participants blood In a separate study the investigators will test if the blood and immune cells from the participants blood can be given safely to the participants relative and if the participants cells cause the cancer in the participants relative to shrink
The first two shots the participant would be given are a vaccine called pNGVL4a-SigE7 detoxHSP70 and it contains DNA the blueprint for making proteins This vaccine is given as a shot into a muscle either in the shoulder or in the thigh This will be followed by a third shot called TA-HPV which contains a vaccinia virus that helps the first shot to work by creating the T cells needed to fight cancer After receiving the vaccines the study team will collect the participants immune system cells to give to the participants relative with cancer The collection will either be by bone marrow harvest or collection of the participants circulating blood depending on the group to which the participant and the participants relative are randomized after enrolling in the trial
The use of this heterogeneous vaccination strategy in this research study is investigational which means that the vaccine regimen is not approved for marketing by the Food and Drug Administration FDA The FDA is allowing the use of the vaccine regimen in this study Based on prior clinical studies it is expected that this vaccine regimen and routes of administration will be well tolerated
In this research the investigators will also be collecting blood samples that may also be used in the future by researchers
The first two shots the participant would be given are a vaccine called pNGVL4a-SigE7 detoxHSP70 and it contains DNA the blueprint for making proteins This vaccine is given as a shot into a muscle either in the shoulder or in the thigh This will be followed by a third shot called TA-HPV which contains a vaccinia virus that helps the first shot to work by creating the T cells needed to fight cancer After receiving the vaccines the study team will collect the participants immune system cells to give to the participants relative with cancer The collection will either be by bone marrow harvest or collection of the participants circulating blood depending on the group to which the participant and the participants relative are randomized after enrolling in the trial
The use of this heterogeneous vaccination strategy in this research study is investigational which means that the vaccine regimen is not approved for marketing by the Food and Drug Administration FDA The FDA is allowing the use of the vaccine regimen in this study Based on prior clinical studies it is expected that this vaccine regimen and routes of administration will be well tolerated
In this research the investigators will also be collecting blood samples that may also be used in the future by researchers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None