Bladder CarcinomaREMOVENCT06789224
Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
A study testing CATUVAB in people with Bladder Carcinoma and Prostate Tumor, run by Lindis Bloodcare GmbH at 6 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Carcinoma, Prostate Tumor, Gallbladder Carcinoma
- What is being tested?
- CATUVAB
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 6 sitesGermany
- Study dates
- 15 Feb 2022to 14 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Kliniken der Stadt Köln gGmbH
Cologne, North Rhine-Westphalia, 51109
Klinik für Anästhesiologie, Intensivmedizin und Schmerztherapie Universitätsklinikum Frankfurt
Frankfurt, 60590
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Klinik für Anästhesiologie
Mainz, 55131
Universitätsmedizin Mannheim, Klinik für Urologie und Urochirurgie
Mannheim, 68167
Klinikum Traunstein
Traunstein, 83278
Klinik und Poliklinik für Anästhesiologie, Intensivmedizin, Notfallmedizin und Schmerztherapie Universitätsklinikum Würzburg
Würzburg, 97080
About this study
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
- Being tested
- CATUVAB
- Medical subject headings
- Urinary Bladder Neoplasms, Prostatic Neoplasms, Gallbladder Neoplasms, Endometrial Neoplasms, Stomach Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CATUVABDevice
inducing of aggreation of tumor cells and immune cells via trifunctional antibody and removal of aggregates
| Study group | Role | What they receive |
|---|---|---|
| medical device validation | Other | removal of tumor cells of EpCAM positive tumors during surgery Receives: Device: CATUVAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during surgery only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start15 Feb 2022
- Primary completion25 Nov 2023
- Study completion14 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindis Bloodcare GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Markus Heiss, MD, Study chair, University Köln Merheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789224
- Sponsor's protocol ID
- REMOVE
- Acronym
- REMOVE
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation Study on the Removal of EpCAM-positive Tumour Cells From Blood Collected During Tumour Surgery Using Catumaxomab/Catuvab Device
- ClinicalTrials.gov ID
- NCT06789224
- Acronym / sponsor ID
- REMOVE / REMOVE
- Conditions
- Bladder Carcinoma, Prostate Tumor, Gallbladder Carcinoma, Endometrial Carcinoma, Gastric Carcinoma, Ovarian Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Lindis Bloodcare GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 25 Nov 2023 (actual)
- Study completion
- 14 Apr 2024 (actual)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| medical device validation | Other | Device: CATUVABremoval of tumor cells of EpCAM positive tumors during surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CATUVABinducing of aggreation of tumor cells and immune cells via trifunctional antibody and removal of aggregates | Device | medical device validation |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Heiss, MD study chair
University Köln Merheim
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CATUVAB in people with Bladder Carcinoma and Prostate Tumor, run by Lindis Bloodcare GmbH at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
depletion of EpCAM-positive tumor cells (time frame: during surgery only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.