Phase 1 Bladder Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written consent to participate.
• People aged 18 or older, of any gender.
• People whose bladder cancer has been confirmed by laboratory testing to be a type called urothelial carcinoma, and whose cancer has not responded to BCG treatment (a common bladder cancer therapy).
• People whose cancer falls into one of these categories: carcinoma in situ (CIS, a flat, non-invasive cancer) with or without certain early-stage tumours, or high-grade early-stage tumours (called Ta or T1), all of which have not responded to BCG.
• People who have already had a procedure to remove bladder tumours (called TURBT), with no remaining removable disease (some flat surface cancer remaining is acceptable). People with T1 tumours may need a repeat procedure to confirm the cancer has not grown deeper into the bladder wall.
• People who are not suitable for, or do not wish to have, surgery to remove the bladder (radical cystectomy).
• People with a general health and activity level rated as 0, 1, or 2 on a standard medical scale (meaning able to carry out daily activities, possibly with some limitations).
• People with a life expectancy of at least 2 years.
• People with adequate blood counts and organ function, as assessed by the trial site.
• Women who could become pregnant must have a negative blood pregnancy test, and both women of childbearing potential and male participants must agree to use reliable contraception during the trial.
• People who can provide a tissue sample (either stored from a previous biopsy or a new sample) for research testing.

Who may not be able to join:

• People who have had TURBT, other bladder surgery, pelvic radiation, or certain other bladder procedures within 2 weeks before the first dose.
• People who have previously received certain treatments, including IL-15, IL-2, immune checkpoint therapy (such as anti-PD-1 or PD-L1 medicines), certain chemotherapy, or BCG, unless the cancer has clearly come back or progressed and it has been more than 4 weeks since that treatment ended (some exceptions apply — confirm with trial site).
• People currently participating in another clinical trial of an investigational drug or device.
• People who have not yet recovered from side effects caused by a previous cancer treatment.
• People with a history of bladder cancer that has grown into the muscle wall or spread, or cancer found in the kidneys, renal pelvis, ureter, or prostate urethra — either previously or found during the screening process.
• People who have had another type of cancer within the past 5 years.
• People with an active infection or urinary tract infection currently requiring intravenous antibiotic treatment, within 2 weeks before the first dose.
• People who have had a significant heart or cardiovascular problem within the 6 months before starting the trial.
• People with a known HIV infection or AIDS diagnosis.
• People with active or ongoing hepatitis B or hepatitis C infection.
• People with known or suspected active autoimmune disease (where the immune system attacks the body's own tissues).
• People currently receiving any other cancer treatment, or who regularly take immune-suppressing steroid medicines above a certain dose (more than 10 mg per day of prednisone or equivalent).
• People with a history of serious lung inflammation (pneumonitis), interstitial lung disease, or severe breathing difficulties that required steroid treatment to manage.
• People with a known allergy or intolerance to the study drug, monoclonal antibodies, or their ingredients; or — for those receiving BCG as part of the trial — a known allergy or intolerance to BCG.
• People who previously had to stop BCG treatment due to serious side effects such as blood poisoning, serious infection, or loss of bladder control (applies only to those who would receive BCG as part of this trial).
• People who have had an organ transplant from another person, or who have experienced graft-versus-host disease.
• People who have received a live vaccine within 4 weeks before the first dose.
• People with a known mental health condition or substance use problem that could affect their ability to follow the trial requirements.
• People who are pregnant, breastfeeding, or planning to become pregnant or father a child during the trial period.
• People who the trial investigators consider unsuitable for any other reason (confirm with trial site).

Important: Always verify eligibility with the trial site directly before applying.