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New Gene-Based bladder cancer treatment shows promise in early trial

NCT ID NCT04752722

Disease control Sponsor: enGene, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study tests a new drug called EG-70 (detalimogene) for a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC). The drug is given directly into the bladder through a catheter. The trial includes patients whose cancer did not respond to standard BCG therapy, as well as some high-risk patients who haven't had full BCG treatment. The goal is to see if EG-70 is safe and can shrink or eliminate tumors, potentially offering an alternative to bladder removal surgery.

What this could mean

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

Active substance
EG-70 (detalimogene)
What this could lead to
If successful, this could offer a new treatment option for bladder cancer patients who don't respond to standard BCG therapy, potentially avoiding bladder removal surgery.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of patients initially, so safety and effectiveness are not yet proven. The treatment requires multiple bladder instillations and may cause side effects.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Oct 2030

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

18 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: BCG-unresponsive Patients: 1. BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without coexisting papillary Ta/T1 tumors who are ineligible for or have elected not to undergo cystectomy, and have experienced CIS disease within 12 months of treatment where: adequate BCG regimen consists of at least 2 courses of BCG where the first course (induction) must have included at least 5 or 6 doses and the second course may have included a re-induction (at least 2 treatments) or maintenance (at least 2 doses), and Cis must be documented or indicated by pathology Phase 2 Only: 2. BCG-Naïve or BCG-incompletely treated Patients with CIS or BCG-unresponsive, HG Ta/T1 papillary disease without CIS: -NMIBC with current Cis of the bladder, with or without coexisting papillary Ta/T1 NMIBC tumor(s), who are ineligible for or have elected not to undergo cystectomy, where: either: cohort 2a) no treatment with BCG but may have previously been treated with at least 1 dose of intravesical chemotherapy following transurethral resection of bladder tumor (TURBT) and Cis must be documented or cohort 2b) indicated by pathology incomplete BCG treatment (at least 1 dose and less than the 5+2 doses required for adequate dosing per Cohort 1) or cohort 3) patients who are BCG-unresponsive following adequate treatment, with HG Ta/T1 papillary disease without CIS. All Patients with High Grade NMIBC: 3. Patients who have previously been treated with a checkpoint inhibitor and failed treatment are eligible for inclusion 30 days post-treatment (Phase 1) or 3 months post-treatment (Phase 2). 4. Male or non-pregnant, non-lactating female, 18 years or older. 5. Women of childbearing potential must have a negative pregnancy test at Screening. 6. Female patients of childbearing potential must be willing to consent to using highly effective birth control methods; Male patients are required to utilize a condom for the duration of the study treatment through 3 months post-dose. 7. In Phase 2, for patients with T1 lesions may be eligible after repeat TURBT if pathology shows non-invasive (Ta or less) or no disease. 8. Performance Status: Eastern Cooperative Oncology Group 0, 1, and 2. 9. Hematologic inclusion: a. Absolute neutrophil count \>1,500/mm3. b. Hemoglobin \>9.0 g/dL. c. Platelet count \>100,000/mm3. 10. Hepatic inclusion: a. Total bilirubin must be ≤1.5 x the upper limit of normal (ULN). b. Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤2.5 x ULN. 11. Adequate renal function with creatinine clearance \>30 mL/min 12. Prothrombin time and partial thromboplastin time ≤1.25 x ULN or within the therapeutic range if on anticoagulation therapy. 13. Must have satisfactory bladder function with ability to retain study drug for 60 minutes. Exclusion Criteria: 1. Active malignancies (i.e., progressing or requiring treatment change in the last 24 months). Exceptions allowed under Sponsor review. 2. Concurrent treatment with any chemotherapeutic agent. 3. History of partial cystectomy. 4. Treatment with last therapeutic agent (including intravesical chemotherapy post-TURBT) within 30 days of Screening (prior to the screening biopsy). 5. Patients who have received systemic immunosuppressive medication including high-dose corticosteroids. 6. History of severe asthma or other respiratory diseases. 7. History of unresolved vesicoureteral reflux or an indwelling urinary stent. 8. History of unresolved hydronephrosis due to ureteral obstruction. 9. Participation in any other research protocol involving administration of an investigational agent within 30 Days prior to screening or any prior treatment of NMIBC with any investigational gene or immunotherapy agent. 10. History of external beam radiation to the pelvis or prostate brachytherapy within the last 12 months. 11. History of interstitial lung disease and/or pneumonitis in patients who have previously received a PD-1 or PD-L1 inhibitor therapy. 12. Evidence of metastatic disease. 13. History of difficult catheterization that in the opinion of the Investigator will prevent administration of EG-70. 14. Active interstitial cystitis on cystoscopy or biopsy. 15. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. 16. Known human immunodeficiency virus, Hepatitis B, or Hepatitis C infection. 17. Significant cardiovascular risk (e.g., coronary stenting within 8 weeks, myocardial infarction within 6 months). 18. Hypersensitivity to any of the excipients of the study drug. Exclusionary for Bladder Rinse cohorts: known allergy to polidocanol

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Conditions

The condition(s) this trial relates to.

bladder carcinoma in situ in situ carcinoma non-invasive bladder urothelial carcinoma Non-Muscle Invasive Bladder Neoplasms superficial urinary bladder carcinoma Urinary Bladder Neoplasms

As listed by the trial registrant

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

Non-muscle invasive bladder cancer Non-muscle invasive bladder cancer with carcinoma in situ Superficial bladder cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    100 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Albany Medical College

    RECRUITING

    Albany, New York, 12208, United States

  • Arkansas Urology

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Associated Medical Professionals of NY,

    RECRUITING

    Syracuse, New York, 13210, United States

  • Associated Urologists of North Carolina

    RECRUITING

    Raleigh, North Carolina, 27612, United States

  • Azienda Ospedaliero-Universitaria Sant'Andrea

    RECRUITING

    Rome, 00189, Italy

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 45227, United States

  • CHU Bordeaux Pellegrin

    RECRUITING

    Bordeaux, 33076, France

  • CHU d'Angers

    RECRUITING

    Angers, 49933, France

  • CHU de Lille

    RECRUITING

    Lille, 59000, France

  • CHU de Rauen- Hopital Charles Nicolle

    RECRUITING

    Rouen, 76031, France

  • CHUM Centre Hospitalier de l Universite de Montreal

    RECRUITING

    Montreal, Quebec, Canada

  • Carolina Urologic Research Center, LLC

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Central Ohio Urology Group

    RECRUITING

    Gahanna, Ohio, 43230, United States

  • Chesapeake Urology Research Associates

    RECRUITING

    Hanover, Maryland, 21076, United States

  • Chi Mei Medical Center

    RECRUITING

    Tainan, 71004, Taiwan

  • China Medical University Hospital

    RECRUITING

    Taichung, 40447, Taiwan

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun, Jeollanam-do, 58128, South Korea

  • Clinic Unit of Urology, IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, MI, 20132, Italy

  • Clinical Research Solutions - Helios Clinical Research

    RECRUITING

    Middleburg Heights, Ohio, 44130, United States

  • Colorado Clinical Research

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • Corewell Health Medical Group and Spectrum Health Hospitals

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Duke Health - Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Fondazione Policlinico Universitario "A.Gemelli" IRCCS, Largo

    RECRUITING

    Rome, 00168, Italy

  • Froedtert Hospital / Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 52336, United States

  • Fundacio Puigvert

    RECRUITING

    Barcelona, 08025, Spain

  • Georgia Cancer Center at Augusta University

    RECRUITING

    Augusta, Georgia, 30912, United States

  • Gold Coast University Hospital

    RECRUITING

    Southport, Queensland, 4215, Australia

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

  • Hopital Bichat Claude-Bernard

    RECRUITING

    Paris, 75018, France

  • Hospices Civils de Lyon

    RECRUITING

    Lyon, 69002, France

  • Hospital Clinic Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General Universitario Gregorio Maranon

    RECRUITING

    Madrid, 28007, Spain

  • Hospital General Universitario Morales Meseguer

    RECRUITING

    Murcia, 30008, Spain

  • Hospital Germans Trias i Pujol

    RECRUITING

    Barcelona, 08916, Spain

  • Hospital Quironsalud Madrid (Next Oncology)

    RECRUITING

    Madrid, 28223, Spain

  • Hospital Universitari de Bellvitge

    RECRUITING

    L'Hospitalet de Llobregat, 08907, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Infanta Sofia

    RECRUITING

    Madrid, 28702, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Marqués de Valdecilla,

    RECRUITING

    Santander, 39008, Spain

  • Houston Methodist Hospital - Department of Urology

    RECRUITING

    Houston, Texas, 77030, United States

  • Houston Metro Urology

    RECRUITING

    Houston, Texas, 77027, United States

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • IOB - Hospital Quironsalud Barcelona

    RECRUITING

    Barbera Del Valles, 5-7, Spain

  • Icon Cancer Center Windsor Gardens

    RECRUITING

    Windsor Gardens, South Australia, 5087, Australia

  • Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Istituto Nazionale Tumori IRCCS Fondazione G. Pascale

    RECRUITING

    Naples, 80131, Italy

  • John Hopkins Hospital

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 807, Taiwan

  • Klinik fur Urologie, Uro-Onkologie, spezielle urologische und Roboter-assistierte Chirurgie Universitatsklinikum Koln (AOR)

    RECRUITING

    Cologne, 50937, Germany

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    COMPLETED

    New York, New York, 10016, United States

  • Mayo Clinic

    RECRUITING

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • McGill University Health Center - Glen site

    RECRUITING

    Montreal, Quebec, H4A3J1, Canada

  • Mount Sinai Medical Center

    RECRUITING

    New Haven, New York, 10029, United States

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100, Taiwan

  • New Jersey Urology, LLC

    RECRUITING

    Voorhees Township, New Jersey, 08043, United States

  • Nova Scotia Health Authority

    RECRUITING

    Halifax, Nova Scotia, B3H2Y9, Canada

  • Om Research

    RECRUITING

    San Diego, California, 92123, United States

  • Oregon Health & Science University (OHSU)

    RECRUITING

    Portland, Oregon, 97239, United States

  • Ospedelae Molinette San Giovanni Battista Di Torino

    RECRUITING

    Torino, 10126, Italy

  • Prostate Cancer Centre

    RECRUITING

    Calgary, Alberta, T2V1P9, Canada

  • Roswell Park Cancer Institute

    RECRUITING

    Buffalo, New York, 14263, United States

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, Gyunggi-do, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • Studienpraxis Urologie

    RECRUITING

    Nürtingen, 72622, Germany

  • Sydney Adventist Hospital

    RECRUITING

    Wahroonga, New South Wales, 2076, Australia

  • Sylvester Comprehensive Cancer Center / University of Miami Hospital and Clinics

    RECRUITING

    Miami, Florida, 33136, United States

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 40705, Taiwan

  • The Catholic University of Korea, Soul St. Mary's Hospital

    RECRUITING

    Seoul, 06591, South Korea

  • The George Washington Medical Faculty Associates

    RECRUITING

    Washington D.C., District of Columbia, 20037, United States

  • The Royal Marsden NHS Foundation Trust

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • The University of Alabama at Birmingham Clinical Research Unit (CRU)

    RECRUITING

    Birmingham, Alabama, 35249, United States

  • Thomas Jefferson University, Sidney Kimmel Cancer Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Tower Urology

    RECRUITING

    Los Angeles, California, 90048, United States

  • UC San Diego Moores Cancer Center

    RECRUITING

    La Jolla, California, 92037, United States

  • UNC Chapel Hill Hospital

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • UOC Urologia, IFO- lstituto Tumori "Regina Elena"

    RECRUITING

    Rome, 53 00144, Italy

  • USC/Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • UT Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390, United States

  • Universitaetsklinikum Erlangen

    RECRUITING

    Erlangen, 91054, Germany

  • Universitaetsklinikum Tubingen

    RECRUITING

    Tübingen, 72076, Germany

  • University Health Network, Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • University of California - Irvine Medical Center

    RECRUITING

    Irvine, California, 92697, United States

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Florida

    RECRUITING

    Jacksonville, Florida, 32209, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Texas - MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Virginia Comprehensive Cancer Center

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • Urological Associates of South Arizona

    COMPLETED

    Tucson, Arizona, 85715, United States

  • Urologicum Duisburg

    RECRUITING

    Duisburg, 47169, Germany

  • Urologie Neandertal Mettmann

    RECRUITING

    Mettmann, 40822, Germany

  • Urology Associates, P.C.

    RECRUITING

    Nashville, Tennessee, 37209, United States

  • Urology Austin

    RECRUITING

    Austin, Texas, 78745, United States

  • Urology of Indiana

    RECRUITING

    Greenwood, Indiana, 46143, United States

  • Vancouver Prostate Centre

    RECRUITING

    Vancouver, British Columbia, V5Z1M9, Canada

  • Vanderbilt Univerity Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • lnstitut Bergonie 229 Cour de l'Argonne

    RECRUITING

    Bordeaux, 33076, France

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