Safety, Feasibility, and Dose Study of Aethlon Hemopurifier in Solid Tumor Patients on Pembrolizumab or Nivolumab

The Hemopurifier (HP) is a single-use hollow-fiber plasmapheresis cartridge that is modified to contain an Affinity Resin in the plasma space along the length of the hollow fibers. The Affinity Resin has broad-spectrum avidity for exosomes. As blood enters the HP, exosomes in the plasma are transported via convection and diffusion through pores in the hollow fibers having nominal pore sizes of 200 nm where they contact the affinity matrix. The exosomes are captured by the Affinity Resin and prevented from re-entry into the circulation. Meanwhile, the cellular components of the blood remain within the lumen of the fibers and are excluded from contact with the affinity resin The Hemopurifier treatment will last for 4 hours. During the Hemopurifier treatment, anticoagulation therapy, such as heparin, will be administered to guaranty a systemic anticoagulation The HP is operated via established central access to a patient’s circulatory system and utilizing standard dialysis machines as blood pumps. A central venous dialysis catheter will be placed prior to treatment. The placement of the catheter will be performed by appropriately credentialed physicians using well-established, standardized sterile procedures. Participant will be assigned to a distinct cohort employing a 3+3 design with each patient serving as his or her. Each First 3 patients own control, each cohort will be comprised of 3 patients; enrollment will proceed as follows: If no patients in a given cohort experience a dose limiting toxicities (DLT) or a serious, unanticipated and device related adverse event in the 7 days followup after the last HP treatment, enrollment in the subsequent cohort will begin (first group will start in cohort 1). If 1 patient in a cohort experiences a DLT or a serious, unanticipated and device-related adverse event, 3 additional patients will be enrolled in that cohort; if greater than or equal to 1 of the additional 3 patients in this group experiences a DLT or a serious, unanticipated and device-related adverse event, enrollment will be stopped. Otherwise, enrollment in the subsequent cohort will begin. If greater than or equal to 2 patients in a given cohort experience a DLT, enrollment in the trial will be stopped. if in cohort 1, patient will receive one, 4-hour long treatment only and will receive pembrolizumab or nivolumab right after. (within +3 day if needed). If in cohort 2, patient will receive two, 4-hour long treatment (e.g Monday and Friday) and he will receive pembrolizumab or nivolumab right after the last session( (within +3 day if needed) If in cohort 3, patient will receive three, 4-hour long treatment (e.g Monday, Wednesday, Friday) and he will receive pembrolizumab or nivolumab right after the last session (within +3 day if needed). Following the HP treatment week, every attempt should be made to keep the patient on their anti-PD-1 containing regimen to the 8 week post HP follow-up visit so as not to confound the extracellular vesicle and T cell analyses. The treating physician however may change the patient’s treatment regimen to one not containing nivolumab or pembrolizumab if clinically indicated.