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Can a gene therapy instilled in the bladder fight tough bladder cancer?

NCT ID NCT05704244

Disease control Sponsor: Ferring Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests a gene therapy called FE 999326 (nadofaragene firadenovec) in Japanese patients with high-grade non-muscle invasive bladder cancer that has not responded to BCG treatment. The therapy is given as a liquid instilled into the bladder through a catheter every three months. Researchers will check whether the treatment causes tumors to disappear and how long any response lasts. The goal is to see if this approach can control the cancer and offer an alternative to more invasive procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FE 999326 (nadofaragene firadenovec), a gene therapy solution instilled into the bladder via a catheter every three months
What this could lead to
If it works, this could offer a new treatment option for Japanese patients with high-grade bladder cancer that has not responded to standard BCG therapy, potentially delaying or avoiding the need for bladder removal surgery.
What could go wrong
This is a phase 3 trial with a small group of 25 participants, so results may not apply broadly. The treatment is given directly into the bladder and may cause local irritation or other side effects, and it is not yet known if it will be effective in this population.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

25 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Nov 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have at entry, confirmed by a pathology report: 1. Carcinoma in situ (CIS) only 2. Ta/T1 high-grade disease with concomitant CIS or 3. Ta/T1 high-grade disease without concomitant CIS * Subjects who did not respond to BCG treatment and have a persistent high-grade recurrence within 12 months after BCG was initiated, and those who despite an initial complete response to BCG, relapse with CIS within 12 months of their last intravesical treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG. * Life expectancy \>2 years, in the opinion of the investigator * Eastern Cooperative Oncology Group (ECOG) status 2 or less * Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra * Subjects with prostate cancer on active surveillance at low risk for progression, defined as prostate-specific antigen (PSA) \<10 ng/dL Exclusion Criteria: * Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit. * Current systemic therapy for bladder cancer * Current or prior investigational treatment for BCG unresponsive NMIBC or any other investigational drug within 1 month prior to screening * Current or prior pelvic external beam radiotherapy within 5 years of entry * Use of other adenovirus vector medications, including COVID-19 vaccines, within 2 weeks before and after instillation * History of malignancy of other organ system within past 5 years, except treated basal cell carcinoma or squamous cell carcinoma of the skin and ≤pT2 upper tract urothelial carcinoma at least 24 months after nephroureterectomy. * Subjects who cannot hold instillation for 1 hour * Subjects who cannot tolerate intravesical dosing or intravesical surgical manipulation * Intravesical therapy within 8 weeks prior to beginning trial treatment, with the exception of: * Cytotoxic agents when administered as a single instillation immediately following a TURBT procedure * Previous intravesical BCG therapy * Systemic immunosuppressive therapy within 3 months prior to screening

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Conditions

The condition(s) this trial relates to.

superficial urinary bladder carcinoma urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bladder cancer

Contacts and locations

Locations

  • Ferring Investigational Site

    Nagakute-shi, Aichi-ken, Japan

  • Ferring Investigational Site

    Nagoya, Aichi-ken, Japan

  • Ferring Investigational Site

    Narita-shi, Chiba, Japan

  • Ferring Investigational Site

    Matsuyama, Ehime, Japan

  • Ferring Investigational Site

    Fukuoka, Fukuoka, Japan

  • Ferring Investigational Site

    Hiroshima, Hiroshima, Japan

  • Ferring Investigational Site

    Hakodate-shi, Hokkaido, Japan

  • Ferring Investigational Site

    Sapporo, Hokkaido, Japan

  • Ferring Investigational Site

    Hitachi-shi, Ibaraki, Japan

  • Ferring Investigational Site

    Tsukuba, Ibaraki, Japan

  • Ferring Investigational Site

    Kawasaki-shi, Kanagawa, Japan

  • Ferring Investigational Site

    Yokohama, Kanagawa, Japan

  • Ferring Investigational Site

    Nankoku-shi, Kochi, Japan

  • Ferring Investigational Site

    Tsu, Mie-ken, Japan

  • Ferring Investigational Site

    Sendai, Miyagi, Japan

  • Ferring Investigational Site

    Matsumoto-shi, Nagano, Japan

  • Ferring Investigational Site

    Kashihara-shi, Nara, Japan

  • Ferring Investigational Site

    Okayama, Okayama-ken, Japan

  • Ferring Investigational Site

    Takatsuki-shi, Osaka, Japan

  • Ferring Investigational Site

    Bunkyo-ku, Tokyo, Japan

  • Ferring Investigational Site

    Minato-ku, Tokyo, Japan

  • Ferring Investigational Site

    Mitaka-shi, Tokyo, Japan

  • Ferring Investigational Site

    Toyama, Toyama, Japan

  • Ferring Investigational Site

    Wakayama, Wakayama, Japan

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