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Actively Recruiting
Researchers are conducting a first-in-human Phase 1a/1b open-label study to assess the safety and anti-cancer effects of UBX-303061 in patients with relapsed or refractory B-cell malignancies. This study focuses on various types of B-cell cancers, including chronic lymphocytic leukemia, diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, Waldenström macroglobulinemia, and marginal zone lymphoma. Participants must have received at least two prior treatments or have no available treatment options as determined by their doctor. The study involves giving participants oral doses of UBX-303061, a drug being tested for its safety and how it works in the body. The study has two parts: Phase 1a, where researchers gradually increase doses to find a safe level, and Phase 1b, which expands the treatment to more participants with specific B-cell malignancy types. Treatment may last up to nine months, with careful monitoring for side effects and dose adjustments as needed. During the study, participants will undergo evaluations including safety checks, blood tests, and assessments of how their cancer responds to treatment. Researchers will track any dose-limiting side effects, dose changes, and overall tolerability. The goal is to establish the maximum safe dose and recommended dose for further studies, ensuring close observation throughout the treatment period.