ClinicalTrials.gov record NCT06980116

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Phase 1 Open-label, Multicenter, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of EXS73565 in Participants With Relapsed or Refractory B-cell Malignancies

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 1An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
Age18 years old and older
SexAll
LocationGeorgia, Greece, Moldova, Poland, Spain, Ukraine, United Kingdom
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1, open-label study gives oral EXS73565 to adults with relapsed or refractory B‑cell malignancies to define a safe dose and study how the drug behaves in the body. The study will record side effects, dose-limiting toxicities, drug levels, and early measures of anti‑tumor activity.

What it is studying. The study is testing the safety, tolerability, pharmacokinetics (how the drug behaves in the body), pharmacodynamics (how the drug affects the body), and preliminary anti‑tumor activity of oral EXS73565 in people with relapsed or refractory B‑cell malignancies.

What the researchers hope to learn. To characterize safety and tolerability of EXS73565, identify dose‑limiting toxicities and appropriate dose levels, define pharmacokinetic and pharmacodynamic profiles, and collect preliminary measures of anti‑tumor activity (for example overall response rate, progression‑free survival, duration of response, and overall survival).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of EXS73565 administered orally as a single agent in participants with relapsed/refractory B-cell malignancies.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • EXS73565

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Age ≥18 years at the time of signing the informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Histologically confirmed diagnosis of one of the following B-cell malignancies: chronic lymphocytic leukemia (CLL), including Richter's transformation from CLL, mantle-cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, or waldenström macroglobulinaemia.
  • Participants that have relapsed after standard of care or have progressed during standard of care or are not suitable for standard of care therapy
  • Key

Exclusion criteria

  • Any medical or psychiatric condition that, in the view of the Principal Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.
  • Known central nervous system (CNS) malignancy or primary CNS lymphoma.
  • Concurrent active or previous malignancy (other than the primary lymphoma/CLL for which the participant will be treated on this protocol within 5 years prior to randomization; participants with prior cancers may be enrolled with documented Sponsor approval.
  • Received anticancer therapy, including chemotherapy, immunotherapy, radiation therapy (with the exception of palliative radiotherapy), biologic therapy, cancer-related hormonal therapy, or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will take the study drug EXS73565 by mouth as a single‑agent treatment. Study staff will monitor participants for side effects, measure how the drug behaves in the body (pharmacokinetics and pharmacodynamics), and assess any anti-tumor activity. The study uses dose‑escalation; early safety is specifically evaluated with dose‑limiting toxicities assessed up to 28 days. Assessments and follow-up occur during treatment and for specified periods in the record (some outcomes up to about 434 days; overall survival measured at 12 and 24 months).

How the study is structured. This is a Phase 1, open‑label, single‑group dose‑escalation trial. Participants all receive oral EXS73565 in a single experimental arm; doses are increased in planned steps to find dose‑limiting toxicities and suitable dosing. The study collects side‑effect data, measures of drug levels in the body, and early efficacy endpoints such as response rate and progression measures. There is no placebo or blinding.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in Georgia, Greece, Moldova, Poland, Spain, Ukraine, United Kingdom. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Waldenström macroglobulinemia

Clinical trials63 trials listed for Waldenström macroglobulinemiaEvery trial the registry lists for Waldenström macroglobulinemia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Waldenström macroglobulinemia researchLatest monthly update: September 2026. Includes: Upfront treatment outcomes. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Mar 31, 2025
Primary completion
June 2028 (estimated)
Study completion
December 2028 (estimated)
Target enrollment
85 participants (estimated)
Last updated on registry
Aug 13, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

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

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (17)

  • LLC ARENSIA Exploratory MedicineRecruiting

    Tbilisi, 119 · Georgia

  • Laiko General Hospital of AthensRecruiting

    Athens, 115 26 · Greece

  • University General Hospital of PatrasRecruiting

    Pátrai, 2650 · Greece

  • General Hosptial of Thessaloniko G. PapanikolaouRecruiting

    Thessaloniki, 570 10 · Greece

  • IMSP Institute of Oncology, ARENSIA Exploratory MedicineRecruiting

    Chisinau, MD-2025 · Moldova

  • Pratia MCMRecruiting

    Krakow, 30-727 · Poland

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologi (Copernicus Memorial Hospital)Recruiting

    Lodz, 95-513 · Poland

  • Uniwersytecki Szpital Kliniczny Nr 4 w LublinieRecruiting

    Lublin, 20-090 · Poland

  • Aidport Sp. z o.o. - PPDSRecruiting

    Skórzewo, 60-185 · Poland

  • Hospital Beata Maria AnaRecruiting

    Madrid, 28007 · Spain

Terms used on this page · explanations by MedicalUpdates.ai

pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
pharmacodynamics
What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
relapsed/refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
ECOG
A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
Histologically confirmed
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
relapsed
A condition that improved with treatment and has since returned or worsened.
standard of care
Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
Principal Investigator
The doctor or scientist responsible for running the study at a site or overall.
randomization
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
Sponsor
The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
investigational
A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
5 half-lives
The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
Key Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Key Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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