RecruitingPHASE1INTERVENTIONAL

Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies

This research study is looking at a new medicine, EXS73565, to treat specific B-cell blood cancers that have either returned after treatment or haven't gotten better with standard care. It's a 'Phase 1' study, meaning we're mainly focused on finding a safe dose of the medicine and understanding any side effects. We also want to see how the medicine moves through the body and if it shows any signs of helping to fight the cancer. Participants will take EXS73565 by mouth. This trial is for adults aged 18 and over.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

Enrolment target

Start

31 Mar 2025

Estimated completion

01 Dec 2028

Relapsed or Refractory B-cell Malignancies

What is this study about?

This study is exploring a new oral medication called EXS73565. It's designed for people who have specific types of B-cell blood cancers, such as certain lymphomas or chronic lymphocytic leukaemia (CLL), where their cancer has either come back after previous treatments or hasn't responded well to the usual care. Sometimes, people might also join if standard treatments aren't suitable for them.

The main goal of this particular study, which is a 'Phase 1' trial, is to carefully find the right dose of EXS73565 that is safe for people to take. We also want to understand any side effects the medicine might cause and how it affects the body. While the main focus is on safety, we will also be looking for any early signs that the medicine could be effective in treating these cancers.

Finding new treatments is vital because cancers can sometimes become resistant to existing medicines. Studies like this help us move closer to developing more options for people living with these conditions. It's an important step in understanding EXS73565 before it can be studied in larger groups of people.

Key takeaways

This study is testing a promising new medicine, EXS73565, for certain B-cell cancers.
It's a 'Phase 1' study focusing on finding a safe dose and understanding side effects.
Participants will take the medicine by mouth, with close medical supervision.
It's for adults whose B-cell cancer has returned or not responded to standard treatments.
You have the right to withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with certain types of B-cell blood cancer, such as chronic lymphocytic leukaemia (CLL), mantle-cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, or marginal zone lymphoma. Importantly, your cancer must have come back (relapsed) after standard treatment, not responded to treatment, or your doctors believe standard treatment isn't quite right for you.

There are also some reasons why you might not be able to join. For example, if you have a current cancer in your brain or spinal cord, or if your doctors believe another health issue might make participating unsafe for you. Also, generally, you shouldn't have received other cancer treatments (including chemotherapy or radiotherapy) in the last three weeks or so before starting the study medicine.

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 or older?
Do you have a diagnosis of one of the listed B-cell blood cancers?
Has your cancer come back, or not responded to usual treatments?
Have you generally avoided other cancer treatments in the last three weeks?
Do you feel well enough for normal daily activities most of the time?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be taking the study medicine, EXS73565, by mouth. You'll need to attend regular appointments at the clinic. During these visits, the study team will carry out various checks and tests to see how you are doing, monitor for any side effects, and understand how the medicine is working in your body. This will involve physical examinations, blood tests, and possibly other scans or procedures.

The number of visits and the overall length of time you'll be on the study will depend on how you respond to the treatment and the study plan. You will receive detailed information about what is expected at each stage. There will be ongoing follow-up to monitor your health both during and after you take the study medicine. All study-related medication and assessments will be provided.

Potential risks and benefits

Taking part in a clinical trial may offer some potential benefits, such as access to a new medicine that isn't yet widely available, which might help your condition. It also means you'll have close medical monitoring. However, there are also potential risks, including side effects from the new medicine, some of which may be serious, or the medicine might not work for you. You are 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.

Hospital Fundación Jiménez Diaz
Verified postcode
Madrid, Spain· Recruiting
Hospital Universitario HM Sanchinarro
Verified postcode
Madrid, Spain· Recruiting
St James's University Hospital
Verified postcode
Leeds, United Kingdom· Recruiting
University Hospitals Plymouth NHS Trust
Verified postcode
Plymouth, United Kingdom· Recruiting

Common questions

What is a 'Phase 1' study?

It's the first stage of testing a new medicine in people. The main goal is to find a safe dose and understand any side effects, rather than primarily checking how well it treats the disease.

What does 'relapsed or refractory' mean?

It means your cancer has come back after treatment, or it hasn't responded to standard treatments and continues to grow.

Will I get a placebo (dummy drug)?

No, in this study, all participants will receive the active study medicine, EXS73565.

What kind of cancers are being studied?

This study is for specific types of B-cell blood cancers like certain lymphomas and chronic lymphocytic leukaemia (CLL).

How will I take the medicine?

The medicine, EXS73565, is taken by mouth, likely as a pill or capsule.

How to find out more

Exscientia AI Ltd.

clinicaltrials@recursion.com 385-374-1724 Official trial record

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