AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

An adaptive open-label multicentre phase 1/2 trial, to determine the recommended phase 2 dose of CCTx-001, and to assess safety, tolerability, and clinical activity in patients with relapsed/refractory acute myeloid leukaemia (RESOLVE AML 001)

This study, called RESOLVE AML 001, is looking into a new treatment named CCTx-001 for adults who have a type of blood cancer called acute myeloid leukaemia (AML) that has come back or hasn't responded to previous treatments. It's an early-stage study, split into two main parts. The first part is about finding the best dose of CCTx-001 to use, focusing on its safety and any side effects. The second part will then look more closely at how effective this treatment is at the chosen dose, aiming to see if it can help patients achieve remission. The treatments involved are cyclophosphamide monohydrate and fludarabine phosphate.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

CanCell Therapeutics

Enrolment target

Start

26 Feb 2024

Relapsed/Refractory Acute Myeloid Leukemia (AML)

What is this study about?

This study, known as RESOLVE AML 001, is an important initial step in checking a new treatment called CCTx-001 for a type of blood cancer called acute myeloid leukaemia, or AML. This trial is specifically for adult patients whose AML has either come back after treatment or hasn't responded to previous treatments. The name of the study, 'RESOLVE AML 001', gives it away – 'RESOLVE' hints at finding a solution, and 'AML' tells us it's about this specific cancer.

The study has two main phases, like two steps in exploring a new medicine. The first phase focuses on finding the safest and most effective amount (dose) of CCTx-001 to give. The researchers will be carefully looking for any side effects and how well patients tolerate the new treatment. Once they have a good idea of the right dose, the study moves into its second phase. Here, they will look more closely at how well CCTx-001 works in clearing the cancer cells, aiming to see if it can help patients achieve remission, which means reducing or getting rid of the signs of cancer.

In this study, CCTx-001 is given alongside two established chemotherapy medicines: cyclophosphamide monohydrate and fludarabine phosphate. These are often used in AML treatments already. By bringing these together, the researchers hope to find a new, effective way to tackle AML that's been particularly difficult to treat. Early stage studies like this are crucial for developing new medicines for serious conditions, helping to understand how they work and if they could benefit patients in the future.

Key takeaways

This study is testing a new treatment (CCTx-001) for AML that has come back or not responded to prior treatments.
It aims to find the safest dose of CCTx-001 and then check how well it works.
The new medicine is given with two standard chemotherapy drugs (cyclophosphamide and fludarabine).
It's open to adults aged 18 and over with relapsed or refractory AML.
You will be closely monitored for safety and effectiveness throughout the study.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is designed for adults, aged 18 and over, who have a diagnosis of acute myeloid leukaemia (AML). Your AML must be considered 'relapsed' (meaning it has come back after treatment) or 'refractory' (meaning it has not responded to previous treatments).

There will be other detailed medical checks to ensure the study is safe for you and that the results will be clear. For example, doctors will need to make sure your other organs, like your kidneys and liver, are working well enough to receive the study medicines. They will also look at your general health.

Since this is an early-stage study, it's very specific about who can join to make sure they can accurately assess the new treatment. If you are interested, your doctor will carefully go through all the criteria with you to see if you might be a good fit.

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?
Have you been diagnosed with acute myeloid leukaemia (AML)?
Has your AML come back after treatment, or has it not responded to previous treatments?
Are you generally well enough to consider receiving chemotherapy?
Are you able to attend regular hospital appointments for monitoring and treatment?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new study medicine, CCTx-001, along with two other established chemotherapy medicines. You can expect to have several hospital visits during the study. These visits will involve various tests, such as blood tests, to monitor your health, check for side effects, and see how well the treatment is working. You will also have assessments of your overall well-being and quality of life.

The study is split into two phases. The first phase focuses on finding the right dose and closely watching for any side effects. Once a suitable dose is found, the second phase will then concentrate on how well the treatment works. The exact number of visits and the total duration of your participation will depend on how you respond to the treatment and the stage of the study you join. Your doctors will discuss the full schedule with you before you agree to take part.

Potential risks and benefits

Taking part in a clinical trial might offer the chance to receive a new treatment that isn't widely available yet, which could be beneficial if other treatments haven't worked for your AML. However, like all medicines, particularly new ones and chemotherapy, there's a possibility of side effects. These could range from mild to severe. The study doctors and nurses will closely monitor you to manage any side effects. You are always free to change your mind and withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (4)

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

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Unverified
Germany
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Unverified
Spain
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Unverified
Sweden
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Unverified
France

Common questions

What is CCTx-001?

CCTx-001 is a new medicine being tested in this study for acute myeloid leukaemia (AML) that has come back or hasn't responded to previous treatments. It's an investigational drug.

What does 'relapsed/refractory' mean?

Relapsed means your cancer has returned after treatment. Refractory means your cancer did not respond to previous treatments.

What are Phase 1 and Phase 2 in a clinical trial?

Phase 1 is usually the first time a new medicine is given to people, focusing on finding a safe dose and checking for side effects. Phase 2 then looks at how well the medicine works at that dose.

Will I receive the new drug CCTx-001?

Yes, if you meet the study criteria and decide to participate, you will receive CCTx-001 along with the other named chemotherapy drugs.

How long would I be in the study?

The total duration of your participation will depend on how you respond to the treatment and the specific phase of the study, which your doctor can discuss in detail.