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

January 22, 2025 updated by: Lindis Bloodcare GmbH
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Germany
      • Frankfurt, Germany, 60590
        • Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Universitätsklinikum Frankfurt
      • Mainz, Germany, 55131
        • Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik für Anästhesiologie
      • Mannheim, Germany, 68167
        • Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie
      • Traunstein, Germany, 83278
        • Klinikum Traunstein
      • Würzburg, Germany, 97080
        • Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie Universitätsklinikum Würzburg
    • NRW
      • Köln, NRW, Germany, 51109
        • Kliniken der Stadt Koln gGmbH

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
depletion of EpCAM-positive tumor cells
Time Frame: during surgery only

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

Collaborators and Investigators

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

Sponsor

Lindis Bloodcare GmbH

Investigators

  • Study Chair: Markus Heiss, MD, University Köln Merheim

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 Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Actual)

November 25, 2023

Study Completion (Actual)

April 14, 2024

Study Registration Dates

First Submitted

January 10, 2025

First Submitted That Met QC Criteria

January 22, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REMOVE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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