Investigation of Safety and Tolerability of Catumaxomab in Patients With NMIBC

  • End date
    Dec 30, 2023
  • participants needed
  • sponsor
    Lindis Biotech GmbH
Updated on 19 April 2022
neutrophil count
invasive bladder cancer
bladder tumor
intravesical administration


The purpose of the study is to investigate the safety, tolerability, and preliminary efficacy of the monoclonal bispecific trifunctional antibody Catumaxomab in patients with non-muscle invasive bladder cancer (NMIBC).


The present Phase I dose escalation study (CATUNIBLA) in patients with non-muscle invasive bladder cancer (NMIBC) of high and intermediate risk for progression aims at investigating the therapeutic potential of Catumaxomab applied as intravesical instillation. Catumaxomab is an intact trifunctional bispecific monoclonal antibody and has the molecular targets EpCAM and CD3. It mediates antibody-dependent cellular cytotoxicity against human epithelial tumor cells including bladder cancer.

The study consists of two parts: Part I is dose finding and will investigate 3 sequential cohorts consisting of 3 patients to be enrolled at the specified dose levels. After determination of the dose for Part II an additional number (n=X) of patients will be included at this dose level. Part I and part II have a screening period, 6 week treatment phase and a follow-up phase.

Condition Urinary Bladder Neoplasms
Treatment Catumaxomab
Clinical Study IdentifierNCT04819399
SponsorLindis Biotech GmbH
Last Modified on19 April 2022


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