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

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

Status and phase

Enrolling

Phase 1

Conditions

Relapsed or Refractory B-cell Malignancies

Treatments

Drug: EXS73565

Study type

Interventional

Funder types

Industry

Identifiers

NCT06980116

EXS73565-001

2024-516869-36-00 (EU Trial (CTIS) Number)

2022-003475-42 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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, or marginal zone lymphoma.
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 21 days or 5 half-lives (whichever is longer) before the first dose of the study treatment.