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NCT Number: NCT06980116

Dose Determining Study 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.

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Key information

Conditions

Relapsed or Refractory B-cell Malignancies Blood Protein Disorders Cardiovascular Diseases Chronic Disease Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) Dendritic Cell Sarcoma, Interdigitating Diffuse-large B-cell Lymphoma (DLBCL) Disease Attributes Follicular Lymphoma (FL) Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Histiocytic Disorders, Malignant Histiocytosis Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mantle Cell Lymphoma (MCL) Marginal Zone Lymphoma (MZL) Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Vascular Diseases Waldenstrom Macroglobulinemia Waldenstrom's Macroglobulinemia (WM)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

LLC ARENSIA Exploratory Medicine, Tbilisi, Georgia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EXS73565

Drug

EXS73565 oral administration

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

Study contacts

Contact information is provided by the study sponsor or research team.

Exscientia AI Ltd.

CONTACT

[email protected]

385-374-1724

Sponsors and collaborators

Lead sponsor

Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
May 20, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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