NCT06980116RecruitingPhase 1
Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies
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
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 85 (estimated)
- First submitted
- 12 May 2025
- Start date
- 31 Mar 2025
- Primary completion date
- Jun 2028
- Lead sponsor
- Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
- Diseases
- Diffuse large B-cell lymphoma, Follicular lymphoma, Mantle cell lymphoma, Chronic lymphocytic leukaemia
- NCT number
- NCT06980116
- EU CT number
- 2024-516869-36-00
- EudraCT number
- 2022-003475-42
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 85
- From 31 Mar 2025 to the primary completion date, Jun 2028
- 22 sites in 9 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Suspended |
| MD Anderson Cancer Center Coordinator of this site? Confirm its status | Madrid | Spain | Suspended |
| Hospital Beata María Ana Coordinator of this site? Confirm its status | Madrid | Spain | Suspended |
| Hospital Universitario HM Sanchinarro Coordinator of this site? Confirm its status | Madrid | Spain | Suspended |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Suspended |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| St James's University Hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Recruiting |
| University Hospitals Plymouth NHS Trust, Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Recruiting |
| LLC Arensia Exploratory Medicine Coordinator of this site? Confirm its status | Tbilisi | Georgia | Recruiting |
| Laiko General Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Suspended |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Suspended |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Suspended |
| IMSP Institute of Oncology, ARENSIA Exploratory Medicine Coordinator of this site? Confirm its status | Chisinau | Moldova | Recruiting |
| Pratia MCM Krakow Coordinator of this site? Confirm its status | Krakow | Poland | Suspended |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Suspended |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Suspended |
| Aidport sp z o.o. Coordinator of this site? Confirm its status | Skorzewo | Poland | Suspended |
| Arensia Clinics S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Completed |
| Medical Center of LLC ARENSIA Exploratory Medicine Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.