Hemopurifier device in patients with solid tumours who have stable or progressive disease while on a treatment that includes pembrolizumab or nivolumab - protocol for an Australian safety, feasibility and dose finding study

Sep 30, 2026

Background: Anti-PD-1 immunotherapy has transformed treatment of many solid tumours, yet only 30–40% of patients achieve durable clinical responses. Tumour-derived extracellular vesicles (EVs) may contribute to tumour spread and resistance. This protocol studies whether a lectin-affinity plasmapheresis device, the Hemopurifier, can safely reduce EV concentrations and enhance antitumour T cell activity in patients not improving on anti-PD-1 regimens. Methods: A 3+3 safety, feasibility and dose-finding design with three cohorts assigns patients to receive one, two, or three Hemopurifier treatments over 1 week before next anti-PD-1 dosing. Outcomes include adverse events, safety labs, EV kinetics with rebound, imaging, T cell counts and activity, and survival status, with progression based on a Data and Safety Monitoring Board.

LanguageEnglish

CategoryHealthcare

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Pages8

Reading Time20 min

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Abstract

Background

Methods

Ethics and dissemination

Strengths and limitations of this study

Introduction

Open access Protocol Hemopurifier device in patients with solid tumours who have stable or progressive disease while on a treatment that includes pembrolizumab or nivolumab: protocol for an Australian safety, feasibility and dose finding study Michael P Brown,1,2 Marco Matos,3 Stephen Clarke ,4,5 P Toby Coates ,2,6 Carol Pollock ,7 Jagadeesh Kurtkoti,8,9 Georges Grau,10 Kelly Edinburg,11 Alessio Bloesch,12 Rosalia de Necochea Campion,12 Nyan Y Khin,13 John Shin,14 Steven P LaRosa 12,15 To cite: Brown MP, Matos M, Clarke S, et al. Hemopurifier device in patients with solid tumours who have stable or progressive disease while on a treatment that includespembrolizumab or nivolumab: protocol for an Australian safety, feasibility and dosefinding study. BMJ Open 2026;16:e102581 . doi:10 . 1136/ bmjopen-2025-102581 ► Prepublication history for this paper is available online. To view these files, please visit the journal online ([https://doi](https://doi). org/10 . 1136/bmjopen-2025- 102581) . Received 21 March 2025 Accepted 17 December 2025 © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ Group. For numbered affiliations see end of article. Correspondence to Dr Steven P LaRosa; [slarosamd@aethlonmedical.com](slarosamd@aethlonmedical.com) ABSTRACT Background Immunotherapy with anti-programmed cell death protein 1 (anti-PD-1) inhibitors has revolutionised the treatment of many solid tumours, however, only 30–40% of patients will have a lasting clinical response. Tumour-derived extracellular vesicles (EVs) have been implicated in the spread of solid tumours and resistance to these agents. A lectin-affinity plasmapheresis device called the Hemopurifier (HP) has been developed and shown to remove EVs in vitro and in patients. We hypothesise that the treatment of patients who are not improving on a regimen that includes an anti-PD-1 agent will be safe, decrease EV concentrations and improve antitumour T cell activity. Methods This safety, feasibility and dose-finding study is designed in a 3+3 safety study design with three treatment cohorts. Participants who are determined not to be responding to a regimen that includes an anti-PD-1 agent will be assigned to receive either one, two or three (HP) treatments over a 1-week period prior to their next scheduled dose of anti-PD-1 antibody. Advancement from one cohort to the next will be determined by a Data and Safety Monitoring Board. Data collection will include adverse events, safety labs, EV concentrations and T cell measurements, repeat imaging and survival status. The primary outcome of the study will be the safety of the HP in this population, with additional endpoints to include the kinetics of EV removal and rebound following HP treatment, in addition to the effects on T cell numbers and activity. Ethics and dissemination The clinical protocol and amendment to the study protocol have been approved by the Central Adelaide Local Health Network Human Research Ethics Committee for Royal Adelaide Hospital (reference number 2024/HRE00031) and the Bellberry Human Research Ethics Committee for Pindara Private STRENGTHS AND LIMITATIONS OF THIS STUDY ⇒ Enrols 9–18 patients with solid tumours who have not improved despite a regimen that includes antiProgrammed cell Death protein 1 immunotherapy. ⇒ Evaluates the safety of the Hemopurifier (HP) treatment in patients with cancer. ⇒ Designed to examine the kinetics of extracellular vesicle removal and changes in lymphocyte numbers based on the frequency of HP treatments. ⇒ Lacks a control arm or randomisation in this early study. ⇒ Small participant numbers do not allow for an assessment of clinical efficacy. Hospital and Genesis Care/Royal North Shore Hospital (reference number 2024-06-724-A-6). The Therapeutic Goods Administration has been notified. The clinical trial is listed on the Australian New Zeala

FAQs

What is the purpose of the Hemopurifier study in anti-PD-1 non-responders?

The study aims to evaluate whether Hemopurifier treatment is safe and can decrease extracellular vesicle (EV) concentrations while improving antitumour T cell activity in patients who are not improving on an anti-PD-1 regimen.

How are participants assigned to Hemopurifier treatment dosing?

In a 3+3 safety design with three treatment cohorts, participants not responding to an anti-PD-1 regimen receive either one, two, or three Hemopurifier treatments over a 1-week period before their next scheduled anti-PD-1 dose.

What will be measured as the primary and secondary outcomes?

The primary outcome is safety of Hemopurifier treatment in this population. Secondary endpoints include EV removal kinetics and rebound, effects on T cell numbers and activity, adverse events, safety labs, repeat imaging, and survival status.

Sep 30, 2026

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