A Phase I Study of 2141-V11 Immunotherapy in People with Non-Muscle Invasive Bladder Cancer that Did Not Respond to Standard Treatment

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Full Title

Phase I Study Evaluating the Safety and Tolerability of an Intravesical Anti-CD40 Agonist Antibody (2141-V11) in Subjects with Non-muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guerin Therapy

Purpose

The purpose of this study is to find the highest dose of the investigational immunotherapy 2141-V11 that can be given safely in people with bladder cancer that has not invaded the bladder muscle wall, has come back after BCG therapy, and will not be surgically removed. The drug 2141-V11 attaches to a protein on immune cells and activates the immune system to find and kill bladder cancer cells. It is given directly into the bladder through a catheter (flexible tube).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have bladder cancer that has not invaded the muscle wall, came back after BCG therapy, and will not be surgically removed.
  • At least 2 weeks must pass since finishing previous treatment and receiving the study therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Bernard Bochner at 646-422-4387.

Protocol

21-314

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator