Phase I Study to Assess Safety and Tolerability of ONO-4685 Alone in Patients With Relapsed or Refractory T Cell Lymphoma and Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

What this Trial Is About

Researchers are evaluating the tolerability and safety of a drug called ONO-4685 when given alone to patients with relapsed or refractory T Cell Lymphoma and Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma CLLSLL. This is an open-label Phase I trial designed to identify potential side effects and appropriate dosing in these patient groups where standard therapies may no longer work or are unavailable. ONO-4685 is administered through intravenous infusion and will be given repeatedly until the disease progresses or unacceptable side effects occur. The study does not include a control group and focuses solely on the effects of ONO-4685 in these patients. The trial includes a dose escalation phase to find the best tolerated dose. Participants will be closely monitored for safety and effectiveness for about one year. This includes tracking any dose-limiting toxicities, adverse events, and changes in vital signs like body temperature, pulse, and blood pressure. Laboratory tests, chest X-rays, and ECGs will be performed regularly. Researchers will also assess tumor response, survival outcomes, and various pharmacokinetic measures during the study period.

A Phase I Study to Investigate the Tolerability and Safety of ONO-4685 Given as Monotherapy in T Cell Lymphoma and CLL/SLL