Clinical trial Recruiting at 17 sites Phase 1 Interventional Ages 18 and up

Testing EXS73565 for patients with relapsed or refractory B-cell cancers

Official title: 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

Run by Exscientia AI Limited · NCT06980116 · Data updated 2026-11-12

This study is testing a new oral medication called EXS73565 to see if it can help adults with B-cell cancers that haven't responded to other treatments.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment85 (estimated)
SponsorExscientia AI Limited
Industry-sponsored
Drugs / interventionschemotherapy, immunotherapy, radiation
Locations17 sites (Tbilisi and 16 other locations)
StatusRecruiting
StartedMarch 31, 2025
Main results expectedJune 2028
Study endsDecember 2028
Registry record updatedAugust 13, 2026
Trial IDNCT06980116 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults with relapsed or refractory B-cell malignancies who have exhausted standard treatment options.

Probably not a fit

Patients with active central nervous system malignancies or those with concurrent malignancies may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of the oral medication EXS73565 in patients with relapsed or refractory B-cell malignancies. Participants will be adults aged 18 and older who have been diagnosed with specific types of B-cell cancers and have not responded to standard treatments. The study will involve administering EXS73565 as a single agent to assess its effects on the targeted malignancies.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat B-cell malignancies.

How similar studies have gone: Other studies have shown promise with similar approaches in targeting B-cell malignancies, but this specific treatment is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Key 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.

Where it's running

  • LLC ARENSIA Exploratory Medicine
    Tbilisi, Georgia
    Recruiting
  • Laiko General Hospital of Athens
    Athens, Greece
    Recruiting
  • University General Hospital of Patras
    Pátrai, Greece
    Recruiting
  • General Hosptial of Thessaloniko G. Papanikolaou
    Thessaloniki, Greece
    Recruiting
  • IMSP Institute of Oncology, ARENSIA Exploratory Medicine
    Chisinau, Moldova
    Recruiting
  • Pratia MCM
    Krakow, Poland
    Recruiting
Show 11 more locations
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologi (Copernicus Memorial Hospital)
    Lodz, Poland
    Recruiting
  • Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
    Lublin, Poland
    Recruiting
  • Aidport Sp. z o.o. - PPDS
    Skórzewo, Poland
    Recruiting
  • Hospital Beata Maria Ana
    Madrid, Spain
    Recruiting
  • MD Anderson Cancer Center Madrid
    Madrid, Spain
    Recruiting
  • Hospital Fundación Jiménez Diaz
    Madrid, Spain
    Recruiting
  • Hospital Universitario HM Sanchinarro
    Madrid, Spain
    Recruiting
  • Clinica Universidad de Navarra
    Pamplona, Spain
    Recruiting
  • Medical Center of LLC ARENSIA Exploratory Medicine
    Kyiv, Ukraine
    Recruiting
  • St James's University Hospital
    Leeds, United Kingdom
    Recruiting
  • University Hospitals Plymouth NHS Trust (Derriford Hospital)
    Plymouth, United Kingdom
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Rocbrutinib and Lacutoclax in B-cell cancers

    This study tests whether Rocbrutinib plus Lacutoclax can help adults with B-cell malignancies, including CLL/SLL, MCL, DLBCL, FL, WM, who have had prior therapy or are treatment-naïve under specific criteria.

    Recruiting Phase 1/2 Guangzhou Lupeng Pharmaceutical Company LTD. · Tianjin · NCT07609862

  • Registry platform for patients with blood cancers in Germany

    This study is setting up a national registry to collect information from patients with blood cancers in Germany to see how well different treatments work and what patients need.

    Recruiting iOMEDICO AG · Freiburg im Breisgau · NCT06043011

  • Evaluating NX-5948 for advanced B-cell cancers

    This study is testing a new drug called NX-5948 to see if it can safely help adults with tough-to-treat B-cell cancers feel better.

    Recruiting at 53 sites Phase 1 Nurix Therapeutics, Inc. · Duarte, California and 61 other locations · NCT05131022

  • Evaluating NX-2127 for adults with advanced B-cell cancers

    This study is testing a new treatment called NX-2127 to see if it can help adults with advanced B-cell cancers feel better and fight their disease.

    Recruiting at 7 sites Phase 1 Nurix Therapeutics, Inc. · Duarte, California and 15 other locations · NCT04830137

  • Safety testing of LTZ-301 in adults with relapsed or refractory B‑cell non-Hodgkin lymphoma

    This trial will test whether LTZ-301 is safe and how it behaves in adults whose B‑cell non-Hodgkin lymphoma has come back or not responded after at least two prior treatments.

    Recruiting at 6 sites Phase 1 LTZ Therapeutics, Inc. · Duarte, California and 5 other locations · NCT07121946

  • Real-world data collection for lymphoma and patient survival

    This study is trying to gather real-life information from lymphoma patients to see how different factors affect their treatment success and long-term survival.

    Recruiting at 37 sites Hospices Civils de Lyon · Arras and 36 other locations · NCT03869619

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.