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

ConditionsRelapsed 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)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

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

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.