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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 85 (estimated) |
| Sponsor | Exscientia AI Limited Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 17 sites (Tbilisi and 16 other locations) |
| Status | Recruiting |
| Started | March 31, 2025 |
| Main results expected | June 2028 |
| Study ends | December 2028 |
| Registry record updated | August 13, 2026 |
| Trial ID | NCT06980116 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
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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
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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
- Study coordinator: Exscientia AI Ltd.
- Email: clinicaltrials@recursion.com
- Phone: 385-374-1724
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.