Evaluation of ARC-02 Alone or with Rituximab in Adults with B-cell Non-Hodgkin Lymphoma Assessing Safety, Effects, and Dosage

What this Trial Is About

Researchers are studying ARC-02 to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and early signs of effectiveness in adults with B-cell Non-Hodgkin Lymphoma NHL. This phase 1 trial focuses on patients with various subtypes of B-cell NHL who have received at least two prior systemic therapies and are not eligible for standard treatments. Participants receive ARC-02 through intravenous infusion on Day 1 of each treatment cycle. Some participants receive ARC-02 alone, while others receive it combined with rituximab, also given by infusion. The treatment continues until the disease progresses or unacceptable side effects occur. The study has dose escalation and dose expansion parts to determine the appropriate dosing levels for both ARC-02 alone and in combination with rituximab. During the study, participants are monitored for dose-limiting toxicities, treatment-emergent adverse events, and serious adverse events for up to five years. Researchers also assess the tumor response and pharmacokinetic measures such as drug concentration in the blood. Participants undergo regular evaluations to track safety and treatment effects, with the overall participation lasting several years to capture long-term data.

A Study of ARC-02 in B-cell NHL