A Study Comparing Immunopheresis® Alone or In Combination With Chemotherapy Versus Chemotherapy Alone in Treatment of Advanced Breast Cancer Patients

PHASE1/PHASE2UnknownINTERVENTIONAL
Enrollment

170

Participants

Timeline

Start Date

May 31, 2019

Primary Completion Date

December 31, 2022

Study Completion Date

July 31, 2023

Conditions
Advanced Breast Cancer
Interventions
OTHER

Plasma soluble TNF receptor pulldown

The Immunoadsorption affinity column, the LW-02 column, uses a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses.

OTHER

Plasma soluble TNF receptor pulldown + chemotherapy

"The Immunoadsorption affinity column, the LW-02 column, uses a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses.~In combined treatment arm the Immunopheresis® procedure is combined with low dose chemotherapy to potentially enhancing the latter's cytotoxic effect."

DRUG

Chemotherapy Drugs, Cancer

Low dose chemotherapy will be provided to patient either IV or oraly depending on the regimen used.

Trial Locations (5)

34662

NOT_YET_RECRUITING

Altunizade Acıbadem Hospital, Istanbul

30-688

RECRUITING

Katedra i Klinika Onkologii UJ CM, Krakow

85-605

RECRUITING

Centrum Medyczne INTERCOR Sp. z o.o., Bydgoszcz

20-954

RECRUITING

Klinika Pneumonologii, Onkologii i Alergologii SPSK Nr 4 w Lublinie, Lublin

60-185

SUSPENDED

Centrum Medyczne Pratia Poznań, Skórzewo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Immunicom Inc

INDUSTRY

NCT04004910 - A Study Comparing Immunopheresis® Alone or In Combination With Chemotherapy Versus Chemotherapy Alone in Treatment of Advanced Breast Cancer Patients | Biotech Hunter | Biotech Hunter