Status:
RECRUITING
Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies
Lead Sponsor:
Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Conditions:
Relapsed or Refractory B-cell Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 parti...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06980116
Start Date
March 31 2025
End Date
December 1 2028
Last Update
December 3 2025
Active Locations (4)
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1
Hospital Fundación Jiménez Diaz
Madrid, Spain
2
Hospital Universitario HM Sanchinarro
Madrid, Spain
3
St James's University Hospital
Leeds, United Kingdom
4
University Hospitals Plymouth NHS Trust
Plymouth, United Kingdom