Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

An open-label phase 1/2 study to evaluate the safety, biological response and efficacy of a single dose of Temferon (autologous CD34+-enriched hematopoietic stem and progenitors cells genetically modified with human Interferon-α2) in patients with metastatic renal cell carcinoma

This research study is looking into a new treatment called Temferon for people with kidney cancer that has grown or spread, and where current treatments haven't worked well enough. Temferon is a type of gene therapy that uses your own cells. The main goal is to see how safe Temferon is and if your body can tolerate it. Researchers will also look at how Temferon affects the cancer and if it helps to slow down or stop its growth. The study involves a few different medications and aims to understand if this new approach could be a helpful option in the future for this type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Genenta Science S.p.A.

Enrolment target

Start

30 Sep 2024

Patients with locally advanced/metastatic renal cell carcinoma with evidence of disease progression following standard of care treatment

What is this study about?

This study is for people in the UK who have advanced kidney cancer that has spread to other parts of the body (this is called metastatic renal cell carcinoma). It's for those whose cancer has continued to grow even after they've had standard treatments. The study is hoping to find new ways to treat this type of cancer.

The main aim of this research is to test a new treatment called Temferon. Temferon is a special type of medicine made from your own cells. It's designed to help your body fight the cancer. The study will look closely at whether Temferon is safe for patients and how well their bodies cope with it. They will also check if Temferon has an effect on the cancer itself.

This study is happening in two stages (Phase 1 and Phase 2). The first stage usually involves a smaller group of people and focuses on safety and finding the right dose. The second stage then checks more broadly how well the treatment works. By taking part, you could be helping doctors learn more about advanced kidney cancer and potentially develop new treatments for the future.

Key takeaways

This study tests a new gene therapy (Temferon) for advanced kidney cancer.
It's for people whose cancer has progressed despite previous treatments.
The main goals are to check safety, how well the body accepts Temferon, and its effect on cancer.
Participation involves several medications and regular health monitoring.
You can leave the study anytime without affecting your other medical care.

Who may be eligible?

This study is primarily for adults, 18 years old or older, both men and women, who have a specific type of advanced kidney cancer.

To be considered for this study, your kidney cancer must have spread to other parts of your body, and it must have continued to get worse even after you've received your usual treatments for it.

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 kidney cancer that has spread?
Has your cancer gotten worse even after trying standard treatments?
Are you willing to have regular medical check-ups and take different medications?

Answer every question to see your result.

What does participation involve?

If you join this study, doctors will keep a very close eye on your health through regular check-ups, blood tests, and scans. You will receive several different medicines as part of the treatment, including Temferon. Temferon is given after a special process that involves collecting some of your own cells and modifying them. You will also receive other medications, some to prepare your body for Temferon and some to help your blood cells recover.

After you receive Temferon, you will have regular follow-up appointments for a period of time to monitor for any side effects and to see how your cancer is responding. This monitoring will continue for at least one year. Your overall health and how you're feeling will also be checked regularly.

Potential risks and benefits

Participating in this study might offer a chance to try a new treatment that isn’t widely available yet, which could potentially help your cancer. However, as with any new treatment, there are potential risks, and you may experience side effects from the medications given. The study team will carefully monitor you for these and provide support. It's very important to remember that you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What is Temferon?

Temferon is a new type of treatment made using your own body cells, designed to help fight your cancer.

Who can join this study?

Adults with advanced kidney cancer that has progressed despite standard treatments can join.

What will happen if I join?

You will receive several medicines, including Temferon, and have regular health checks for about a year to see how you respond.

What are the main goals of the study?

The study aims to see how safe Temferon is, how your body tolerates it, and if it helps to control your cancer.

Will I still receive my normal care?

Yes, you will continue to receive good medical care, and you can leave the study at any time without it affecting your other treatments.