NCT06980116 Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies
| NCT ID | NCT06980116 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc. |
| Condition | Relapsed or Refractory B-cell Malignancies |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 85 participants in total. It began in 2025-03-31 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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, 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 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 14 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06980116 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed or Refractory B-cell Malignancies. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06980116 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06980116 currently recruiting?
Yes, NCT06980116 is actively recruiting participants. Contact the research team at clinicaltrials@recursion.com for enrollment information.
Where is the NCT06980116 trial being conducted?
This trial is being conducted at Tbilisi, Georgia, Chisinau, Moldova, Madrid, Spain, Madrid, Spain and 5 additional locations.
Who is sponsoring the NCT06980116 clinical trial?
NCT06980116 is sponsored by Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.. The trial plans to enroll 85 participants.