Study on Intravesical Recombinant Mycobacterium for Patients with Non-Muscle Invasive Bladder Cancer Eligible for Tice BCG

Sponsor: ImmunityBio, Inc.

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06800963

Provider View

This clinical trial is testing a new treatment using a modified bacteria, given directly into the bladder, for patients with non-muscle invasive bladder cancer (NMIBC) who have not yet received BCG treatment. The study includes patients with specific types of bladder cancer that have been confirmed by a doctor.

Patient Parameters

Program Overview

The purpose of this study is to evaluate a new treatment involving a modified form of bacteria called Recombinant Mycobacterium Bacillus Calmette-Guérin (rMBCG) for patients with non-muscle invasive bladder cancer (NMIBC). This treatment is given directly into the bladder. The study is open to patients who have not previously received BCG treatment and have been diagnosed with certain types of bladder cancer, such as carcinoma in situ (CIS) or specific papillary tumors, after undergoing a procedure to remove bladder tumors.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of non-muscle invasive bladder cancer (NMIBC) that has not been treated with BCG before.
  • Have either carcinoma in situ (CIS) or specific types of papillary tumors after a procedure to remove bladder tumors.
  • No remaining tumors that can be removed after the procedure, except for CIS.
  • Be in relatively good health with a performance status score of 0, 1, or 2.
  • Agree to participate and follow all study procedures, including signing a consent form.

Exclusion Criteria

  • Life expectancy of less than 2 years.
  • Certain abnormal blood test results, such as low white blood cell or platelet counts, or high liver or kidney function tests.
  • History of more advanced bladder cancer or other cancers within the past 5 years, except for certain skin or cervical cancers.
  • Severe heart problems or recent heart attack.
  • Uncontrolled brain or nervous system disease.
  • Active infections requiring IV antibiotics or other serious infections.
  • Use of high-dose steroids or other immune-suppressing medications.
  • Women who are pregnant or breastfeeding, or not using effective birth control.
  • Currently receiving other cancer treatments or investigational drugs.
  • Any other serious medical or psychiatric conditions that could interfere with the study.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.