Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

A Phase 1 Study of PRT2527 as Monotherapy and in Combination with Zanubrutinib or Venetoclax in Participants with Relapsed/Refractory Hematologic Malignancies

This research study, called a Phase 1 trial, is looking at a new medicine called PRT2527. It's designed for adult patients in the UK who have certain types of blood cancer, such as chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL), or other related conditions, that have returned or not improved with past treatments. The main goal is to find out if PRT2527 is safe to use, what dose works best, and how it affects the body. Sometimes PRT2527 will be given alone, and sometimes it will be given together with other existing cancer drugs like zanubrutinib or venetoclax. This early stage study helps doctors understand new treatments before they can be used more widely.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Prelude Therapeutics Inc.

Enrolment target

109

Start

14 Sep 2023

What is this study about?

This research study is an early stage, or Phase 1, clinical trial. Its main purpose is to carefully check if a new medicine called PRT2527 is safe for people to take and to understand how it behaves in the body. Researchers will also be looking for the best dose to use. They want to see if this new drug might help people with specific types of blood cancer that are advanced or have come back after other treatments. These cancers include chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL), and some types of non-Hodgkin's lymphoma, among others.

In this study, some patients will receive PRT2527 on its own. Others will receive PRT2527 alongside other medicines already used to treat cancer, such as zanubrutinib or venetoclax. This is to see if combining these drugs is also safe and potentially more effective than PRT2527 by itself. It's important to remember that as this is a Phase 1 study, the focus is primarily on safety and understanding the drug, rather than how well it treats the cancer at this very early stage.

Taking part in a study like this is a crucial step in developing new treatments for serious illnesses. While it won't be known if PRT2527 works for your specific cancer during this early phase, the information gathered will be vital for future research that could eventually lead to new options for many patients. Your participation would help doctors learn more about these complex conditions.

Key takeaways

It's a Phase 1 study, focusing on safety and dosage of a new drug, PRT2527.
For adults with certain blood cancers (leukaemia/lymphoma) that haven't responded to previous treatment.
The new drug may be given alone or combined with other existing cancer medicines.
Participation involves regular hospital visits for tests and monitoring.
You can withdraw from the study at any time without affecting your medical care.
This study plays a vital role in developing future treatments, though direct benefit isn't guaranteed.

Who may be eligible?

To join this study, you must be at least 18 years old. It is open to both men and women.

You would be considered for this study if you have certain types of blood cancer, like chronic lymphocytic leukaemia (CLL), mantle cell lymphoma (MCL), or other specific lymphomas and leukaemias. Crucially, your cancer must have either come back after previous treatments or not responded well to them.

There will be other detailed health checks to make sure the study is safe for you. For example, your general health, organ function, and any other medical conditions will be carefully reviewed by the study doctors. These checks are in place to protect your safety and ensure the study results are as accurate as possible.

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 a diagnosis of one of the listed blood cancers (e.g., CLL, MCL, AML)?
Has your cancer come back or not improved after prior treatments?
Are you able to travel to study appointments regularly?
Are you able to understand and agree to the study requirements?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a series of tests to make sure you are suitable. Once enrolled, you would receive the study medicine, PRT2527 (either alone or with other drugs), for a set period. This medicine might be given as tablets or through a drip.

Throughout the study, you would have regular hospital visits. These visits will involve blood tests, physical examinations, and possibly other scans or procedures to monitor your health, check for any side effects, and see how the medicine is working. The number and frequency of visits would vary, especially at the beginning, but will become less frequent over time.

The total duration of your participation in the study could range from several months to a year or more, depending on how your body responds to the treatment and the study plan. Even after you stop taking the study medication, there will be follow-up appointments to monitor your long-term health.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might not directly benefit from the study treatment in this early phase, but the information gathered could help future patients. You might also receive more frequent medical attention than you would normally. However, new drugs can have side effects that are not yet fully known. These could range from mild to serious. The study team will monitor you closely for any side effects and explain all known risks before you decide to take part. You are always free to 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.

—
Unverified
Germany
—
Unverified
Poland
—
Unverified
Italy
—
Unverified
France

Common questions

What is a Phase 1 study?

A Phase 1 study is the first step in testing a new drug in humans. It focuses mainly on safety, finding the right dose, and understanding how the drug works in the body.

What kind of conditions is this study for?

This study is for adults with specific types of blood cancers, such as certain leukaemias and lymphomas, that have not responded well to past treatments or have returned.

Will I definitely get the new drug?

Yes, if you join this study, you will receive the new drug, PRT2527. Sometimes it will be given alone, and sometimes with another existing cancer medicine.

Can I stop taking part if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your regular medical care.

Will this drug cure my cancer?

As this is an early stage study, we don't know yet if this drug will cure cancer. The main goal is to check for safety and how the drug behaves in the body. Any positive effects on your cancer would be a secondary observation.