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.

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Key information

Conditions

Bladder Carcinoma Abdominal Neoplasms Adenocarcinoma Adnexal Diseases Biliary Tract Diseases Biliary Tract Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Hepatocellular Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Colon Carcinoma Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Carcinoma Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gallbladder Carcinoma Gallbladder Diseases Gallbladder Neoplasms Gastric Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Kidney Carcinoma Kidney Diseases Kidney Neoplasms Liver Carcinoma Liver Diseases Liver Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non-small Cell Lung Cancer Ovarian Carcinoma Ovarian Diseases Ovarian Neoplasms Pancreatic Carcinoma Pancreatic Diseases Pancreatic Neoplasms Peritoneal Carcinomatosis Peritoneal Diseases Peritoneal Neoplasms Prostate Tumor Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kliniken der Stadt Köln gGmbH, Cologne, North Rhine-Westphalia, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CATUVAB

Device

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Lindis Bloodcare GmbH

Industry

Registry information

Acronym: REMOVE

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2024
First posted: Jan 23, 2025
Registry last updated: Jan 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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