Validation Study On The Removal Of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device

Study Overview

Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device

The REMOVE study was an open-label, multicenter validation study on the removal of EpCAM-positive tumor cells from blood collected during tumor surgery using the CATUVAB Kit. The aim of the REMOVE clinical study was to demonstrate the safety and efficacy of the application of the new medical device CATUVAB to allow retransfusion of autologous erythrocyte product produced by an intraoperative blood salvage (IBS) device during oncological high blood loss surgery. The primary objective of the study was to demonstrate that CATUVAB device utilized during autologous blood salvage procedures (including LDFs) depletes intraoperative blood of EpCAM-positive tumor cells.

N/A

Bladder Carcinoma
Prostate Tumor
Gallbladder Carcinoma
Endometrial Carcinoma
Gastric Carcinoma
Ovarian Carcinoma
Pancreatic Carcinoma
Colon Carcinoma
Non-small Cell Lung Cancer
Peritoneal Carcinomatosis
Kidney Carcinoma
Liver Carcinoma

DEVICE: CATUVAB

REMOVE

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2025-01-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-01-22
First Submitted that Met QC Criteria 2025-01-22	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-01-23
First Posted (ACTUAL) 2025-01-23	Results First Posted N/A	Last Verified 2025-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
OTHER: medical device validation removal of tumor cells of EpCAM positive tumors during surgery	DEVICE: CATUVAB inducing of aggreation of tumor cells and immune cells via trifunctional antibody and removal of aggregates

Participant Group/Arm

Intervention/Treatment

OTHER: medical device validation

removal of tumor cells of EpCAM positive tumors during surgery

DEVICE: CATUVAB

inducing of aggreation of tumor cells and immune cells via trifunctional antibody and removal of aggregates

Primary Outcome Measures	Measure Description	Time Frame
depletion of EpCAM-positive tumor cells	Tumor cell count (Depletion) measured with Immun-histo chemistry staining and tumor cell counting in a Neubauer Chamber * a depletion to ≤10 cells per 100 mL EC, OR * if <100.000 tumor cells have been detected before in IBS: a depletion by at least a factor of 103 in the EC (total) as compared to collected intraoperative blood (total), OR * if ≥100.000 tumor cells have been detected before in IBS: a depletion by at least a factor of 5x103 in the EC (total) as compared to collected intraoperative blood (total), in at least 95% of subjects after one IBS/LDF cycle using the Catuvab device. The primary endpoint will only be determined in subjects with EpCAM-positive tumor cells in salvaged blood and who receive retransfusion of the EC	during surgery only

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Intraoperative blood salvage (IBS)-eligible according to the Investigator
Patients with a prostate tumor, gallbladder carcinoma, bladder carcinoma, endometrial carcinoma, gastric carcinoma, ovarian carcinoma, pancreatic carcinoma, colon / rectal carcinoma, non-small cell lung cancer, or peritoneal carcinomatosis, i.e., cancer types with a high likelihood of being EpCAM-positive (>92%) OR kidney carcinoma or liver carcinoma.
For patients with cancer types with a high likelihood of being EpCAM-positive (>92%): if a tumor tissue sample is available and has been EpCAM tested or EpCAM-testing can be done within 5 days of signing the informed consent form (ICF): results of EpCAM typing should be positive.
For patients with kidney carcinoma or liver carcinoma: a tumor tissue sample must be available and have tested EpCAM-positive prior to surgery.
Scheduled for surgery to remove tumor.
The Investigator expects that at least 400 mL full blood can be collected during the tumor surgery.
An American Society of Anesthesiologists (ASA) Classification of ≤3.

Adjuvant therapy and intra-operative chemotherapy (hyperthermic intraperitoneal hemotherapy, HIPEC) started before blood collection for IBS is completed.
Lymphocytopenia (count <1.0 x 109 /L lymphocytes).
Cancer different from indicated types, especially typically EpCAM-negative tumor types.
Sepsis occurring during surgery.
Cirrhosis of the liver with a Child-Pugh score of C.
A thrombocyte count of <30.000/µL.
Allergies and/or contraindications against Catumaxomab or any of the components or ingredients used in the IBS procedure (e.g., leukocyte depletion filter [LDF], diluent, buffer solution or anticoagulants).
Active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, confirmed by a positive polymerase chain reaction (PCR) test prior surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Markus Heiss, MD, University Köln Merheim

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record