ClinicalTrials.gg
RecruitingNCT06980116Updated Aug 13, 2026

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

A Phase 1 interventional study of EXS73565 in Relapsed or Refractory B-cell Malignancies, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) and Follicular Lymphoma (FL), sponsored by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.. Recruiting at 17 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Primary conditionLeukemia, Lymphocytic, Chronic, B-CellRegistry: RecurrenceReclassifiedWhy we changed it
Registry
Recurrence — the first condition term the registry derived for this study.
ClinicalTrials.gg
Leukemia, Lymphocytic, Chronic, B-Cell
Why
  1. Recurrence describes something many studies share rather than a condition a study is about.
  2. The study's listed conditions name Leukemia, Lymphocytic, Chronic, B-Cell.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2025; still recruiting 1 year 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
85
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • 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)
  • Waldenstrom's Macroglobulinemia (WM)

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
03

In context

Leukemia, Lymphocytic, Chronic, B-Cell Reclassified

2,036 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 237 are open to participants now.

This study's planned enrollment of 85 is above the median of 39 across 1,603 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Browse Leukemia, Lymphocytic, Chronic, B-Cell studies →

Lead sponsor

Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Compared within Leukemia, Lymphocytic, Chronic, B-Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Age ≥18 years at the time of signing the .
  • (ECOG) performance status of 0-1.
  • confirmed diagnosis of one of the following B-cell : 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 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 therapy within 14 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
85 participants (estimated)

Study arms

  • Experimental
    EXS73565

    Drug: EXS73565

Interventions

  • DrugEXS73565

    EXS73565 oral administration

06

What researchers measure

Primary outcomes

  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Time frame: Up to 282 days

  2. Number of Participants With Dose-limiting toxicities (DLTs)

    Time frame: Up to 28 days

Secondary outcomes

  1. Time to Maximum Concentration (Tmax) of EXS73565-001

    Time frame: Up to 253 days

  2. 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

  3. Maximum Concentration (Cmax) of EXS73565-001

    Time frame: Up to 253 days

  4. Overall Response Rate (ORR)

    Time frame: Up to 434 days

  5. Progression Free Survival

    Time frame: Up to 434 days

  6. Duration of Response

    Time frame: Up to 434 days

  7. Time to Respond

    Time frame: Up to 434 days

  8. Time to Progression

    Time frame: Up to 434 days

  9. Overall Survival

    Time frame: 12 and 24 months

07

Study locations

17 of 17 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06980116
Lead sponsor
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
May 20, 2025
Start date
Mar 31, 2025
Primary completion
Jun 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Aug 13, 2026

Study contacts

Exscientia AI Ltd.
Contact
clinicaltrials@recursion.com
385-374-1724

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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