RecruitingPHASE1INTERVENTIONAL

IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas

This study, called IKS03, is looking for volunteers with advanced B-cell non-Hodgkin lymphoma. This includes conditions like diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma. The main goal is to test a new drug, IKS03, to see how safe it is and how well people tolerate it. Researchers also want to find the best dose to use in future studies and to understand how the drug affects the cancer. This is a very early study (Phase 1), which means it’s the first time this specific medicine is being tried in people. It will help us learn important information about this potential new treatment option.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Iksuda Therapeutics Ltd.

Enrolment target

140

Start

05 Sep 2023

Estimated completion

01 Sep 2028

B-cell Non-Hodgkin Lymphoma Diffuse Large B Cell Lymphoma Follicular Lymphoma Mantle Cell Lymphoma B-cell Lymphoma

What is this study about?

This study is investigating a new medicine called IKS03 for people who have advanced B-cell non-Hodgkin lymphoma. This type of cancer affects certain white blood cells. The study is particularly looking for those whose lymphoma has come back, hasn't responded to previous treatments, or for whom typical treatments aren't available.

IKS03 works by targeting a specific protein called CD19 which is found on the surface of some lymphoma cells. The medicine is designed to attach to these cells and deliver a drug right to them. This is an early stage study, often called a Phase 1 study, which means it’s the first time this particular drug is being given to people. Because it's an early study, the main aims are to discover the safest amount of the drug to give, to understand any side effects, and to see if it shows any signs of helping people with their cancer.

The study is split into two parts. In the first part, different groups of people will receive gradually increasing doses of IKS03. This helps the doctors find the highest dose that is safe and tolerable. Once that dose is found, the second part of the study will give that dose to more people to learn more about its effects, how it moves through the body, and how well it works against the cancer.

Key takeaways

This study is for advanced B-cell non-Hodgkin lymphoma.
It tests a new drug, IKS03, for the first time in people.
The main goals are to find a safe dose and look for any benefits.
Participation involves regular visits and monitoring.
You must have tried at least two previous treatments that didn't work or are no longer suitable.
There's no guarantee it will work, but you can stop at any time.

Who may be eligible?

The study is looking for adults aged 18 or older with advanced B-cell non-Hodgkin lymphoma. This includes several types such as diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma. Importantly, your lymphoma must have either already had treatment that didn't work, has come back after treatment, or there are no other standard treatments available. You must also have had at least two previous courses of treatment.

It's important that your lymphoma cells have a specific marker called CD19, as the study drug targets this. You will need to be generally well enough to take part and have a good enough expected lifespan. If you are female and could become pregnant, or you are male and could father a child, you will need to agree to use effective contraception during the study and for several months afterwards.

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 advanced B-cell non-Hodgkin lymphoma that has returned or not responded to past treatments?
Have you had at least two previous treatments for your lymphoma?
Are you generally well enough for a study, with a good expected quality of life?
Are you willing to use effective birth control if you could become pregnant or father a child?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve regular visits to the clinic for check-ups, blood tests, and to receive the study medicine, IKS03. The number and frequency of visits will be explained by the study team. You might need to have a biopsy of your tumor (taking a small sample for examination) before starting the treatment and potentially during the study, especially if your cancer seems to be responding well. The total duration of your participation will depend on how you respond to the treatment and the stage of the study you are in, but the study team will provide a clear timeline. You will be closely monitored for any side effects.

Potential risks and benefits

Potential risks of taking part in any drug study include experiencing side effects. Since IKS03 is a new medicine, not all side effects are known, but the study team will monitor you very closely. There's also no guarantee that the treatment will help your cancer. However, by taking part, you could potentially benefit from a new treatment that might help where others haven't, and you would be contributing vital information that could help others with similar conditions in the future. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual care.

Locations (13)

University of Maryland Baltimore
Verified postcode
Baltimore, United States· Withdrawn
Westmead Hospital
Verified postcode
Westmead, Australia· Recruiting
Royal Adelaide Hospital
Verified postcode
Adelaide, Australia· Recruiting
Royal Hobart Hospital
Verified postcode
Hobart, Australia· Recruiting
Linear Clinical Research
Verified postcode
Perth, Australia· Recruiting
Jewish General Hospital
Verified postcode
Montreal, Canada· Recruiting
La Fondazione e l'Istituto di Candiolo
Verified postcode
Candiolo, Italy· Recruiting
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Ospedale San Raffaele
Verified postcode
Milan, Italy· Recruiting
Istituto Europeo Clinico Humanitas
Verified postcode
Milan, Italy· Recruiting
Istituto Europeo di Oncologia
Verified postcode
Milan, Italy· Recruiting
Institut Catala D'Oncologia
Verified postcode
Badalona, Spain· Recruiting
Hospital Universitario Quironsalud Madrid
Verified postcode
Madrid, Spain· Recruiting

Common questions

What is B-cell non-Hodgkin lymphoma?

It's a type of cancer that starts in certain white blood cells called B-cells, which are part of your immune system.

What does 'advanced' mean in this study?

It means the lymphoma has progressed or come back after previous treatments, or it's a type that is harder to treat.

What is a 'Phase 1' study?

It's the first time a new medicine is given to people. The main goal is to check for safety and find the right dose.

Can I still get other treatments while on this study?

You will receive the study drug, IKS03. Your doctor will discuss if you can have any other treatments at the same time.

Will I have to pay to be part of the study?

No, you don't have to pay to participate in clinical trials. The study drug and related tests are covered by the trial.

How to find out more

David Browning

david.browning@iksuda.com 615-975-7776 Official trial record

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