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

A Study to Learn More About an Investigational Medicine called HDP-102 in Patients with Relapsed/Refractory B-cell Blood Cancers.

This important trial is investigating a new medication called HDP-102. It's designed for people who have B-cell blood cancers that have either returned after treatment (relapsed) or haven't gotten better with standard therapies (refractory). This is a very early stage of research, often called a Phase I study. This means it's the first time this medicine is being given to people. The main goals are to learn more about how HDP-102 acts in the body, its safety, and what doses might be effective. By taking part, you could help doctors understand more about this potential new treatment for serious blood cancers.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Heidelberg Pharma AG
Enrolment target
28
Start
12 Mar 2025

What is this study about?

Imagine your body has tiny soldiers called B-cells that help fight off infections. Sometimes, these B-cells can grow out of control and cause a type of cancer, like lymphoma or leukaemia. When these cancers come back after treatment, or don't get better with the usual medicines, it can be very challenging.

This study is looking at a new medicine called HDP-102. This medicine is still experimental, which means it hasn't been approved for general use yet. The scientists want to understand how it works inside the body, what kind of side effects it might have, and if it could potentially help people with these types of B-cell blood cancers.

Because this is the very first time HDP-102 is being given to people (we call this 'Phase I'), the main focus is on safety and finding the right dose. It's a crucial step in developing new treatments, and participants play a very important role in helping medical science advance.

Key takeaways

  • This study is for adults with specific B-cell blood cancers that have returned or not responded to existing treatments.
  • It's testing a new, experimental medicine called HDP-102 for the first time in people.
  • The main goals are to check the medicine's safety and how it works in the body.
  • Participation involves regular hospital visits for monitoring and assessments.
  • You'll get access to a potential new treatment and contribute to medical research.
  • You can stop participating at any time if you change your mind.

Who may be eligible?

This study is open to adults aged 18 and over, with no upper age limit. Both men and women are welcome to take part.

To be considered for this study, you must have a B-cell blood cancer that has either returned after you've had treatment for it (this is called 'relapsed') or hasn't responded to the treatments you've already tried (this is called 'refractory'). Your doctors will be able to confirm if your specific cancer fits these descriptions.

There will also be other specific medical checks and tests to make sure that taking part in the study would be safe for you. Your study doctor and nurse will discuss all of these details with you.

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 a B-cell blood cancer?
  3. Has your cancer come back after treatment or not responded to previous treatments?
  4. Are you able to attend regular hospital appointments?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be given the investigational medicine, HDP-102. This will involve regular visits to the hospital or clinic so the study team can carefully monitor how you are doing. During these visits, they will carry out various assessments, which might include blood tests, physical examinations, and asking you how you are feeling.

The frequency of visits might be higher at the beginning of the study to ensure your safety as the new medicine is introduced. The total length of your participation in the study will depend on how you respond to the treatment and what the doctors decide is best for your health. There will also be follow-up appointments after you stop taking the medicine to continue monitoring your health.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment that isn't yet widely available, and helping others by advancing medical knowledge. However, there are also potential risks; as this is a new medicine, not all side effects are known, and it might not be effective for everyone. You will be closely monitored for any side effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

Common questions

What is a 'B-cell blood cancer'?

B-cell blood cancers are types of cancer that affect your white blood cells, which are part of your immune system. Common examples include some lymphomas and leukaemias.

What does 'relapsed/refractory' mean?

'Relapsed' means your cancer has come back after treatment. 'Refractory' means your cancer didn't respond or stop growing with the treatments you've had previously.

What is a 'Phase I' study?

A Phase I study is the earliest stage of human testing for a new medicine. Its main aims are to find a safe dose and understand how the medicine works in the body.

Will I definitely get better if I join this trial?

There's no guarantee that participating in any clinical trial will lead to a cure or improvement, especially in early-stage studies. The aim is to understand if the medicine has potential.

Can I leave the study at any time?

Yes, you can choose to leave the study at any point, and you don't need to give a reason. Your decision will not affect your future medical care.

How to find out more

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

Discussion

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