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

NCT ID: NCT06789224

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2024-04-14

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

medical device validation

removal of tumor cells of EpCAM positive tumors during surgery

Group Type: OTHER

CATUVAB

Intervention Type: DEVICE

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

Interventions

CATUVAB

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lindis Bloodcare GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Heiss, MD

Role: STUDY_CHAIR

University Köln Merheim

Locations

Kliniken der Stadt Köln gGmbH

Cologne, North Rhine-Westphalia, Germany

Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Universitätsklinikum Frankfurt

Frankfurt, , Germany

Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik für Anästhesiologie

Mainz, , Germany

Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie

Mannheim, , Germany

Klinikum Traunstein

Traunstein, , Germany

Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie Universitätsklinikum Würzburg

Würzburg, , Germany

Countries

Germany

Other Identifiers

REMOVE

Identifier Type: -

Identifier Source: org_study_id