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Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Study of KITE-222 in Participants With Relapsed/Refractory Acute Myeloid Leukemia

This research study is investigating a new medication, KITE-222, for adults who have acute myeloid leukaemia (AML). AML is a cancer that affects the blood and bone marrow. This particular study is for people whose AML has either returned after being treated before (relapsed) or hasn't improved with standard treatments (refractory). This is a very early stage of testing, often called a Phase I study. The main goal at this stage is to find out if KITE-222 is safe for people to take and how the body reacts to it. Researchers will also be looking to see if there are any side effects. This important first step helps us understand if a new medicine has the potential to help patients in the future.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Kite Pharma Inc.
Enrolment target
10
Start
05 Oct 2023

What is this study about?

This study is exploring a new treatment called KITE-222 for a serious blood cancer known as Acute Myeloid Leukaemia, or AML. AML affects the white blood cells in your body. In this study, doctors are looking for adults whose AML has come back after previous treatment, or for those whose AML hasn't responded well to the treatments they've already tried.

This is a very early step in testing new medicines, often called a 'first-in-human' study. It means that KITE-222 has not been given to people before, only studied in laboratories. The main purpose of this initial stage is to check if the new treatment is safe for people to take and to understand how their bodies handle the medication. The researchers will be looking very closely for any side effects and how much of the drug can be given safely.

Finding new ways to treat AML, especially for those whose cancer is difficult to manage, is really important. Studies like this help to identify potential new medicines that might one day offer more options and hope for people living with this illness. Even though it's an early study, it's a crucial step in developing future treatments.

Key takeaways

  • This study is testing a new drug, KITE-222, for AML.
  • It's for adults whose AML has come back or not responded to prior treatments.
  • The main aim is to check the safety of the new treatment.
  • Participation involves regular hospital visits for treatment and monitoring.
  • There might be potential benefits, but also unknown risks, as it's a new medicine.
  • You can stop participating at any time if you wish to.

Who may be eligible?

To join this study, participants need to be adults, meaning they must be 18 years old or older. There is no upper age limit for taking part.

Both men and women are welcome to participate in this research. The study is specifically looking for people who have Acute Myeloid Leukaemia (AML) that has either returned after being treated before or hasn't gotten better with standard treatments.

Before joining, doctors will carefully check your overall health and medical history to make sure the study treatment is suitable and safe for you. They will explain all the requirements in detail.

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.

  1. Are you 18 years old or older?
  2. Do you have Acute Myeloid Leukaemia (AML)?
  3. Has your AML come back after treatment, or is it not responding to treatment?
  4. Are you able to attend regular hospital appointments?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have a number of tests to check if the study is right for you. These might include blood tests, physical exams, and other checks related to your AML. Once you're approved, you'll receive the new study medicine, KITE-222, according to a schedule set by the doctors. This will involve regular visits to the hospital or clinic for treatments, check-ups, and more tests to see how you are responding and to monitor for any side effects.

The research team will closely watch your health throughout the study. After your treatment period, there will be follow-up visits to continue monitoring your health and any long-term effects of the medication. The total length of your participation, including treatment and follow-up, will be explained by the study team, and it can vary for each person.

Potential risks and benefits

Taking part in a study like this means you might be among the first to try a new treatment. While there's no guarantee the treatment will help your AML, it could potentially offer a new option where others haven't worked, and your participation helps advance medical knowledge for future patients. However, because KITE-222 is new, not all its side effects are known, and there could be serious or unexpected risks. The study team will explain all known or potential risks. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

Common questions

What is Acute Myeloid Leukaemia (AML)?

AML is a type of cancer that starts in the bone marrow, the soft tissue inside your bones where blood cells are made. It affects the white blood cells.

What does 'relapsed/refractory' mean?

It means your AML has either come back after being treated before (relapsed) or it hasn't improved with previous treatments (refractory).

What is a Phase I study?

A Phase I study is the first time a new medicine is given to people. The main goal is to check how safe it is and how much of it can be given safely.

Will I get paid to be in the study?

Researchers will explain if there's any financial reimbursement for your time or travel, but the primary reason to join a study is to potentially benefit from the treatment and contribute to medical science.

How long will I be in the study?

The full length of time depends on your individual response and the study plan, but the research team will explain this in detail before you decide to join.

How to find out more

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

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