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

NCT06980116 | Recruiting Phase 1 DMC

• 3 other identifiers: EXS73565-0012024-516869-36-002022-003475-42
• Study Type: interventional
• Target: 85
• Locations: 5 countries
• Sites: 9

Brief 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.

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); 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

Outcome Measures

Primary Outcomes (2)

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

  Up to 282 days

• Number of Participants With Dose-limiting toxicities (DLTs)

  Up to 28 days

Secondary Outcomes (9)

• Time to Maximum Concentration (Tmax) of EXS73565-001

  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

  Up to 253 days

• Maximum Concentration (Cmax) of EXS73565-001

  Up to 253 days

• Overall Response Rate (ORR)

  Up to 434 days

• Progression Free Survival

  Up to 434 days

Study Arms (1)

EXS73565

EXPERIMENTAL

Drug: EXS73565

Interventions

EXS73565 DRUG

EXS73565 oral administration

EXS73565

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (9)

LLC ARENSIA Exploratory Medicine

Tbilisi, 119, Georgia

RECRUITING

IMSP Institute of Oncology, ARENSIA Exploratory Medicine

Chisinau, MD-2025, Moldova

RECRUITING

Hospital Beata Maria Ana

Madrid, 28007, Spain

RECRUITING

Hospital Fundación Jiménez Diaz

Madrid, Spain

RECRUITING

Hospital Universitario HM Sanchinarro

Madrid, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, 31008, Spain

RECRUITING

Medical Center of LLC ARENSIA Exploratory Medicine

Kyiv, 01135, Ukraine

RECRUITING

St James's University Hospital

Leeds, United Kingdom

RECRUITING

University Hospitals Plymouth NHS Trust (Derriford Hospital)

Plymouth, United Kingdom

RECRUITING

MeSH Terms

Conditions

Recurrence; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Mantle-Cell; Dendritic Cell Sarcoma, Interdigitating; Waldenstrom Macroglobulinemia

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Histiocytic Disorders, Malignant; Histiocytosis; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Central Study Contacts

Exscientia AI Ltd.

CONTACT

385-374-1724; clinicaltrials@recursion.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: May 20, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2); ES (4); GE (1); MO (1); UA (1)