Relapsed or Refractory B-cell MalignanciesPhase 1NCT06980116
Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies
A Phase 1 study testing EXS73565 in people with Relapsed or Refractory B-cell Malignancies and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), run by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. at 17 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory B-cell Malignancies, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Follicular Lymphoma (FL)
- What is being tested?
- EXS73565
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 17 sitesin 7 countries
- Study dates
- 31 Mar 2025to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
17 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
17 sites in 7 countries
Spain5 sites, 5 recruiting
- Recruiting
Hospital Beata Maria Ana
Madrid, 28007
- Recruiting
MD Anderson Cancer Center Madrid
Madrid, 28033
- Recruiting
Hospital Fundación Jiménez Diaz
Madrid
- Recruiting
Hospital Universitario HM Sanchinarro
Madrid
- Recruiting
Clinica Universidad de Navarra
Pamplona, 31008
Poland4 sites, 4 recruiting
- Recruiting
Pratia MCM
Krakow, 30-727
- Recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologi (Copernicus Memorial Hospital)
Lodz, 95-513
- Recruiting
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
Lublin, 20-090
- Recruiting
Aidport Sp. z o.o. - PPDS
Skórzewo, 60-185
Greece3 sites, 3 recruiting
- Recruiting
Laiko General Hospital of Athens
Athens, 115 26
- Recruiting
University General Hospital of Patras
Pátrai, 2650
- Recruiting
General Hosptial of Thessaloniko G. Papanikolaou
Thessaloniki, 570 10
United Kingdom2 sites, 2 recruiting
- Recruiting
St James's University Hospital
Leeds
- Recruiting
University Hospitals Plymouth NHS Trust (Derriford Hospital)
Plymouth
Georgia1 site, 1 recruiting
- Recruiting
LLC ARENSIA Exploratory Medicine
Tbilisi, 119
Moldova1 site, 1 recruiting
- Recruiting
IMSP Institute of Oncology, ARENSIA Exploratory Medicine
Chisinau, MD-2025
Ukraine1 site, 1 recruiting
- Recruiting
Medical Center of LLC ARENSIA Exploratory Medicine
Kyiv, 01135
About this study
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
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.
- Conditions
- Relapsed or Refractory B-cell Malignancies, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), Mantle Cell Lymphoma (MCL), Diffuse-large B-cell Lymphoma (DLBCL)
- Being tested
- EXS73565
- Keywords
- B-cell Malignancies, Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), Mantle Cell Lymphoma (MCL), Diffuse-large B-cell Lymphoma (DLBCL), Waldenstrom's Macroglobulinemia (WM), MALT1
- Medical subject headings
- Recurrence, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell, Dendritic Cell Sarcoma, Interdigitating, Waldenstrom Macroglobulinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXS73565Drug
EXS73565 oral administration
| Study group | Role | What they receive |
|---|---|---|
| EXS73565 | Experimental | Not described Receives: Drug: EXS73565 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to 282 days
Number of Participants With Dose-limiting toxicities (DLTs)
Measured: Up to 28 days
Secondary outcomes (9)
Time to Maximum Concentration (Tmax) of EXS73565-001
Measured: Up to 253 days
Area Under the Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration AUC(0-last) of EXS73565-001
Measured: Up to 253 days
Maximum Concentration (Cmax) of EXS73565-001
Measured: Up to 253 days
Overall Response Rate (ORR)
Measured: Up to 434 days
Progression Free Survival
Measured: Up to 434 days
Duration of Response
Measured: Up to 434 days
Time to Respond
Measured: Up to 434 days
Time to Progression
Measured: Up to 434 days
Overall Survival
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start31 Mar 2025
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory B-cell MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980116
- Sponsor's protocol ID
- EXS73565-001
- Other IDs
- 2024-516869-36-00, 2022-003475-42
- Status last verified
- Aug 2026
- First submitted
- 12 May 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06980116
- Acronym / sponsor ID
- EXS73565-001
- Conditions
- Relapsed or Refractory B-cell Malignancies, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), Mantle Cell Lymphoma (MCL), Diffuse-large B-cell Lymphoma (DLBCL)
- Keywords
- B-cell Malignancies, Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), Mantle Cell Lymphoma (MCL), Diffuse-large B-cell Lymphoma (DLBCL), Waldenstrom's Macroglobulinemia (WM), MALT1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXS73565 | Experimental | Drug: EXS73565 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXS73565EXS73565 oral administration | Drug | EXS73565 |
Primary outcome
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 282 days
Number of Participants With Dose-limiting toxicities (DLTs)
Time frame: Up to 28 days
9 secondary outcomes
Time to Maximum Concentration (Tmax) of EXS73565-001
Time frame: Up to 253 days
Area Under the Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration AUC(0-last) of EXS73565-001
Time frame: Up to 253 days
Maximum Concentration (Cmax) of EXS73565-001
Time frame: Up to 253 days
Overall Response Rate (ORR)
Time frame: Up to 434 days
Progression Free Survival
Time frame: Up to 434 days
Duration of Response
Time frame: Up to 434 days
Time to Respond
Time frame: Up to 434 days
Time to Progression
Time frame: Up to 434 days
Overall Survival
Time frame: 12 and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
17 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EXS73565 in people with Relapsed or Refractory B-cell Malignancies and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), run by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. at 17 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Spain, Poland, Greece, United Kingdom, Georgia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Exscientia AI Ltd. (385-374-1724, clinicaltrials@recursion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 282 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.