RecruitingPHASE1INTERVENTIONAL

Phase 1 Study of Allo-RevCAR01-T-CD123 in Patients With Selected CD123 Positive Hematologic Malignancies

This research is looking at a new treatment called Allo-RevCAR01-T-CD123 for adults aged 18 and over who have a specific type of blood cancer called Acute Myeloid Leukaemia (AML). This AML must have a marker on its cells called CD123 and either have come back after treatment or not responded to standard treatments. This is a very early study (Phase 1). Its main goal is to find out if the treatment is safe and what the best dose is. The treatment involves specially designed immune cells that are meant to find and destroy the cancer cells. It's hoped this new approach could offer a new option for patients whose current treatments are no longer working.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

AvenCell Europe GmbH

Enrolment target

Start

03 Jan 2024

Estimated completion

01 Jan 2028

Acute Myeloid Leukemia, in Relapse Acute Myeloid Leukemia Refractory

What is this study about?

This study is investigating a new and experimental treatment called Allo-RevCAR01-T-CD123. It's designed for people with Acute Myeloid Leukaemia (AML), a type of blood cancer, particularly if their cancer has continued to grow despite standard treatments or has come back after treatment. The AML cells in this study need to have a specific marker on their surface called CD123.

The treatment works by using specially modified immune cells, called Allo-RevCAR01-T. These cells are like tiny soldiers in your body designed to fight illness. However, these specific cells have been given special instructions to recognise and attach to cancer cells. To help them do this, another part of the treatment, called R-TM123, acts like a 'bridge', connecting the specially modified immune cells to the CD123 marker on the cancer cells, so the immune cells can destroy them.

Because this is a Phase 1 study, the main purpose is to see if the new treatment is safe and to figure out the right dose. It's a very early step in testing new medicines, and while it's hoped that this treatment could offer a new way to fight AML, more research will be needed to fully understand its benefits.

Key takeaways

This is an early-stage study (Phase 1) for a new AML treatment.
The treatment uses specially modified immune cells to find and fight cancer.
It's for adults with specific AML that has the CD123 marker.
Participants must have tried or be unable to use standard AML treatments.
The main goals are to check the treatment's safety and find the right dose.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have been diagnosed with Acute Myeloid Leukaemia (AML) that has a specific marker called CD123 on its cells. This means at least 20% of your leukaemia cells must show this marker. Importantly, you would have already tried standard treatments for your AML, and they either haven't worked or your cancer has come back. If there are other treatments that might cure your AML, or if you can't tolerate the ones available, you might also be considered.

Your general health and physical ability will also be checked. For example, your medical team will look at how well you can go about your daily activities, using a scale called ECOG, and you would need to score 0 or 1. Some parts of your genetic makeup (called HLA type) will also need to match very closely for you to be included in the study.

There are also specific rules about the number of leukaemia cells in your bone marrow, especially if your cancer has returned more than twice. The study is very specific about who can participate to ensure the safety and clarity of the results. Your doctor will be able to tell you if you meet these detailed requirements.

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 Acute Myeloid Leukaemia (AML) where standard treatments haven't worked or your cancer has come back?
Has your AML been shown to have a specific marker called CD123?
Are you generally able to perform your daily activities without significant difficulty (ECOG 0 or 1)?
Have you discussed this study with your doctor to confirm it's suitable for you?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have regular visits to the clinic for medical check-ups, tests, and to receive the study treatment. The treatment involves receiving the specially designed immune cells (Allo-RevCAR01-T) and the bridging medicine (R-TM123). Before receiving these, you'll also have other medicines called Cyclophosphamide and Fludarabine. These are given to help prepare your body for the new immune cells.

The study involves several assessments, including blood tests, bone marrow checks, and other scans, to see how you are responding to the treatment and to monitor your health. Your medical team will explain the exact schedule of visits and tests. The total duration of your participation will depend on how you respond to the treatment and the study plan, but there will be ongoing follow-up to monitor your health after the main treatment phase.

Potential risks and benefits

Taking part in an early-stage study like this means you might be among the first to receive a new treatment that could potentially help fight your cancer, especially if standard treatments haven't worked. However, because it's a new treatment, the full benefits are not yet known. There are also potential risks, as any new medicine can have side effects. These will be carefully monitored by the study team, and they will explain all known and possible side effects to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (11)

Universitätsklinikum Ulm
Verified postcode
Ulm, Germany· Recruiting
Klinikum der Universität München
Verified postcode
Munich, Germany· Recruiting
Universitätsklinikum Würzburg
Verified postcode
Würzburg, Germany· Recruiting
Universitätsklinikum Marburg
Verified postcode
Marburg, Germany· Recruiting
Universitätsklinikum Dresden
Verified postcode
Dresden, Germany· Recruiting
Charité Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting
Universitätsklinikum Köln
Verified postcode
Cologne, Germany· Recruiting
Medizinische Hochschule Hannover
Verified postcode
Hanover, Germany· Recruiting
Erasmus University Medical Center
City only
Rotterdam, Netherlands· Recruiting
Amsterdam University Medical Center
Verified postcode
Amsterdam, Netherlands· Not yet recruiting
University Medical Center Groningen (UMCG)
Verified postcode
Groningen, Netherlands· Not yet recruiting

Common questions

What is AML?

AML stands for Acute Myeloid Leukaemia. It's a type of cancer that starts in the bone marrow, the soft inner part of your bones, and affects the blood-forming cells.

What does CD123 positive mean?

CD123 is a specific marker or protein found on the surface of some cancer cells. For this study, your AML cells need to have this marker for the treatment to potentially work.

What is a Phase 1 study?

A Phase 1 study is the first step in testing a new treatment in humans. Its main goal is to find out if the treatment is safe, what side effects it might have, and to figure out the right dose.

Will this treatment cure my cancer?

It's too early to know if this treatment will cure cancer. This is a very early study focusing on safety and dosage. While it aims to fight cancer cells, its effectiveness is still being researched.

Can I continue with my current treatments?

Participation in this study usually means you will receive the experimental treatment instead of your current cancer treatments. Your doctor will discuss this with you and explain all options.

How to find out more

Katja Jersemann, Dr.

avc-201-01@avencell.com 0493514466450 Official trial record

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