RecruitingPHASE1, PHASE2INTERVENTIONAL

LEGEND Study: EG-70 in NMIBC Patients BCG-Unresponsive and High-Risk NMIBC Incompletely Treated With BCG or BCG-Naïve

This research study, called LEGEND, is looking at a new treatment called EG-70 for a type of bladder cancer that hasn't spread deep into the bladder wall (non-muscle invasive bladder cancer). This could be cancer that hasn't gotten better with BCG treatment, or for some people who are newly diagnosed or haven't had enough BCG. The study has two main parts: first, a small group will check the best and safest dose of EG-70, and then a larger group will see how well it works. EG-70 is given directly into the bladder to target cancer cells and aims to boost the body's own immune system to fight the cancer effectively, while trying to limit side effects elsewhere in the body.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

enGene, Inc.

Enrolment target

350

Start

22 Apr 2021

Estimated completion

30 Nov 2028

Superficial Bladder Cancer Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

What is this study about?

This study, called LEGEND, is investigating a new treatment named EG-70 for a specific type of bladder cancer. This cancer is called 'non-muscle invasive bladder cancer' (NMIBC), meaning it's only on the surface layers of the bladder and hasn't grown into the deeper muscle. Doctors are particularly interested in NMIBC that includes 'carcinoma in situ' (CIS), a more aggressive form of NMIBC.

The main goal of the study is to see how safe EG-70 is and how well it works. EG-70 is a new type of gene therapy that isn't based on a virus. It's designed to be put directly into your bladder. The idea is that once it's in the bladder, it will encourage your body's immune system to attack the cancer cells right where they are. This 'local' treatment means it only works in the bladder, hopefully boosting its cancer-fighting effect while keeping side effects to a minimum elsewhere in your body.

The study is split into two parts. The first part (Phase 1) is about finding the safest dose of EG-70. Once that's determined, the second part (Phase 2) will test how effective this dose is in treating people with NMIBC. The study is particularly looking for people whose bladder cancer hasn't responded to standard treatments like BCG, or those who haven't received BCG treatment yet or had incomplete BCG treatment.

Key takeaways

This study tests a new bladder cancer treatment (EG-70).
It's for non-muscle invasive bladder cancer (NMIBC), often when BCG hasn't worked.
EG-70 aims to use your body's immune system to fight cancer locally.
Treatment is given directly into the bladder.
The study has two parts: finding the right dose, then seeing how well it works.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you generally need to be at least 18 years old. The researchers are looking for people with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC) that includes 'carcinoma in situ' (CIS).

Specifically, they are interested in people whose bladder cancer hasn't improved after previous BCG treatment (known as 'BCG-unresponsive'). They are also considering people newly diagnosed with NMIBC with CIS who haven't had BCG before, or those who started BCG but didn't complete the full treatment. If you've had a type of NMIBC called papillary disease (HG Ta/T1) that's BCG-unresponsive but without CIS, you might also be eligible.

It's important that you or your doctor have decided against or are unable to have surgery to remove the bladder (cystectomy). Women who might become pregnant must use effective birth control, and men must use condoms during and for a period after treatment to prevent pregnancy.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS)?
Has your bladder cancer not responded to BCG treatment, or have you not had BCG, or had incomplete BCG treatment?
Have you or your doctor decided against bladder removal surgery (cystectomy)?
If you are a woman who could become pregnant, are you willing to use effective birth control?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll receive the study drug, EG-70, directly into your bladder. This happens over four cycles, with each cycle lasting 12 weeks. During these cycles, you'll have regular check-ups and assessments to monitor your health and how the treatment is working against the bladder tumors.

If your cancer responds well and you have no signs of cancer after these first four cycles, you might then enter a 'maintenance' phase. This could involve up to four more cycles of EG-70 treatment, followed by continued monitoring. The total time you'd be involved in the study, including treatment and follow-up, could be quite long. Your study team will explain the schedule of visits, tests, and treatments in detail.

Potential risks and benefits

Participating in a clinical trial like this means you might be among the first to receive a new treatment that could potentially improve your bladder cancer, especially if other treatments haven't worked well. However, because EG-70 is new, there's a chance it might not work for you, or it could cause side effects that aren't yet fully known. As with any medical treatment, there are potential risks, and the study team will monitor you closely for any unwanted effects. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (101)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The University of Alabama at Birmingham Clinical Research Unit (CRU)
Verified postcode
Birmingham, United States· Recruiting
Mayo Clinic
Verified postcode
Scottsdale, United States· Recruiting
Urological Associates of South Arizona
Verified postcode
Tucson, United States· Completed
Arkansas Urology
Verified postcode
Little Rock, United States· Recruiting
University of California - Irvine Medical Center
Verified postcode
Irvine, United States· Recruiting
UC San Diego Moores Cancer Center
Verified postcode
La Jolla, United States· Recruiting
USC/Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States· Recruiting
Tower Urology
Verified postcode
Los Angeles, United States· Recruiting
Om Research
Verified postcode
San Diego, United States· Recruiting
Colorado Clinical Research
Verified postcode
Lakewood, United States· Recruiting
The George Washington Medical Faculty Associates
Verified postcode
Washington D.C., United States· Recruiting
University of Florida
Verified postcode
Jacksonville, United States· Recruiting

Common questions

What type of bladder cancer is this study for?

It's for non-muscle invasive bladder cancer (NMIBC), especially with 'carcinoma in situ' (CIS), or high-grade papillary disease, that hasn't responded to BCG or is newly diagnosed/incompletely treated.

What is EG-70 and how is it given?

EG-70 is a new gene therapy designed to boost your immune system to fight cancer. It's given directly into your bladder as a liquid.

Will I have to have major surgery?

No, this study is for people who are not having or cannot have surgery to remove the bladder ('cystectomy').

How long will I be in the study?

You'll be treated for up to four 12-week cycles, and if you respond well, you could have up to eight more maintenance cycles, plus follow-up appointments. The total duration can be quite long.

Are there any age restrictions?

Yes, you must be 18 years or older to participate.

How to find out more

enGene clinical trials

clinicaltrials@engene.com +18572991097 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.