Ignite Creation Date:
2024-05-06 @ 2:54 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04453046
Status:
TERMINATED
Last Update Posted:
2022-12-20
First Post:
2020-06-20
Brief Title:
Hemopurifier Plus Pembrolizumab in Head and Neck Cancer
Sponsor:
Aethlon Medical Inc
Organization:
Aethlon Medical Inc
Study Overview
Official Title:
Depleting Exosomes to Improve Response to Immune Therapy in Head and Neck Squamous Cell Cancer An Early Feasibility Phase I Clinical Trial
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Eligible subjects at study site
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an Early Feasibility Study EFS investigating the use of the Hemopurifier to clear immunosuppressive exosomes in combination with pembrolizumab Keytruda in the front line setting in patients with advanced andor metastatic squamous cell carcinoma of the head and neck
Detailed Description:
All 12 patients enrolled into this Early Feasibility Phase I clinical trial will receive the same treatment of Hemopurifier plus Pembrolizumab ie 2 rounds of Hemopurifier plus Pembrolizumab followed by Pembrolizumab only up to 2 years Prior to initiation of the Hemopurifier treatment on Day 1 each subject will undergo phlebotomy to provide a baseline EDTA anti-coagulated blood sample 30ml 3 tablespoons of blood for the assessments of total exosome protein TEP levels and exosome profiles The kinetics of exosome depletion will be evaluated in the study participants using serial blood samples 5ml collected hourly during the 4h-depletion period by the Hemopurifier on Day 1 In addition to evaluate kinetics of exosome recovery 30ml of blood will be collected just prior to Pembrolizumab infusion day 1 and on days 7 and 14 after Hemopurifier plus Pembrolizumab treatment during cycle 1 and 2 Exosome recovery after Hemopurifier Pembrolizumab therapy will be evaluated and used to determine the rate of TEP recovery for each patient Serial monitoring of TEP during Hemopurifier treatment hourly during the 4h-depletion period before Pembrolizumab infusion and after the second round of Pembrolizumab days 7 and 14 will be done as for the first treatment Only 2 Hemopurifier treatments will be given For third and later rounds of Pembrolizumab the investigators will continue to draw 30mL blood prior to Pembrolizumab infusion for the assessments of TEP levels and exosome profiles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None