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

Launched by EXSCIENTIA AI LIMITED · May 12, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new drug called EXS73565 for patients with certain types of B-cell cancers that have come back after treatment or did not respond to previous therapies. The main goals are to find out how safe the drug is, how the body processes it, and whether it can help shrink tumors. The trial is currently looking for participants aged 18 and older who have specific types of B-cell malignancies, such as chronic lymphocytic leukemia or lymphoma, and who have already tried other treatments without success.

If you decide to join this study, you will take the medication by mouth and be monitored closely by the research team for any side effects and to see how well the medication works. It's important to note that some people may not qualify for the trial if they have certain medical conditions or have recently received other cancer treatments. This study is an opportunity to contribute to research that could help improve treatment options for B-cell cancers in the future.

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Eligibility 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.