NCT04453046

Hemopurifier Plus Pembrolizumab in Head and Neck Cancer

Depleting Exosomes to Improve Response to Immune Therapy in Head and Neck Squamous Cell Cancer: An Early Feasibility Phase I Clinical Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Aethlon Medical Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 and/or 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 (i.e., 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.

Conditions

• Squamous Cell Carcinoma of the Head and Neck

Interventions

Type	Name	Description
DEVICE	Hemopurifier	Two Hemopurifier treatments on Day 1 and Day 21
DRUG	Pembrolizumab 200mg IV	Pembrolizumab 200mg IV will be administered every 21 days. One cycle is 21 days. All patients will be treated with Pembrolizumab for up to 34 cycles

Timeline

• Start date: 2020-10-22
• Primary completion: 2022-11-14
• Completion: 2022-11-14
• First posted: 2020-07-01
• Last updated: 2022-12-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study