Phase 2 Bladder Cancer Trial, Recruiting NCT06800963 Sponsor: ImmunityBio, Inc. Condition: Bladder Cancer
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Phase 2 Bladder Cancer Trial, Recruiting

NCT06800963
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older
  • You have been diagnosed with a type of bladder cancer called non-muscle invasive urothelial carcinoma (a cancer that has not grown deep into the bladder wall), confirmed by a tissue sample, and you have never received BCG treatment for it
  • Your bladder cancer is either a specific flat type (called CIS, with or without other growths), or you have had early-stage tumour growths (called Ta or T1) removed by surgery
  • After your bladder surgery, there is no remaining tumour that could be surgically removed (some types of residual disease may still be acceptable — confirm with trial site)
  • You are generally well enough to carry out light activity and care for yourself, even if you cannot do heavy physical work
  • You are willing and able to give written consent and follow all the study's procedures and check-up visits

Who may not be able to join:

  • Your life expectancy is less than 2 years
  • Your blood test results show very low levels of certain blood cells (white blood cells or platelets) at the time of joining
  • Your blood tests show that your liver is not working well (raised liver enzyme levels above a certain threshold)
  • Your blood tests show that your kidneys are not working well (raised creatinine levels above a certain threshold)
  • Your bladder cancer has grown into the deeper muscle of the bladder wall, spread locally, spread to other parts of the body, or spread outside the bladder (including into the prostate area)
  • You have had another cancer in the past 5 years that is still active or needs treatment — with some exceptions for certain skin cancers, early-stage cancers in full remission, or stable prostate cancer under monitoring or hormone treatment (confirm with trial site)
  • You have moderate to severe heart failure with noticeable symptoms affecting daily life
  • You have severe chest pain (unstable angina) or have had a heart attack within the past 6 months
  • You have a history of uncontrolled disease of the brain or nervous system
  • You currently have a serious infection that requires antibiotic treatment given through a drip or injection
  • You currently have a fever, an active urinary tract infection, active tuberculosis, or a history of very low blood pressure reactions or severe allergic reactions
  • You need to take steroid tablets every day at a dose higher than a low threshold (more than 10 mg of prednisone or equivalent daily)
  • You are pregnant or breastfeeding
  • You are a woman who could become pregnant and are not willing or able to use an effective form of contraception during the study and for 30 days after the last dose, or have not had a negative pregnancy test before starting
  • You are a man who is not willing to use barrier contraception (such as condoms) during the study and for 90 days after the last dose
  • You are currently receiving any other cancer treatment or taking part in another trial of an experimental cancer therapy (other than the treatment being studied in this trial)
  • You are currently taking any other experimental drugs not approved by regulators (with an exception for certain approved COVID-19 treatments)
  • You have another serious medical condition, mental health condition, or abnormal test result that the study doctor believes would make it unsafe or unsuitable for you to take part

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 310-912-2230

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
ImmunityBio, Inc.
Registry
ClinicalTrials.gov
Start date
15 October 2025
Est. completion
1 February 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

The primary endpoint is to assess safety as measured by the incidence and severity of adverse events.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov