Study of GNC-035 Antibody Treatment for Adults with Relapsed or Refractory Non-Hodgkins Lymphoma Evaluating Safety, Dosage, and Effectiveness in Blood Cancers

What this Trial Is About

Researchers are evaluating GNC-035, a tetra-specific antibody injection, in patients with relapsed or refractory non-Hodgkins lymphoma and other blood cancers. The study aims to observe the safety and initial effectiveness of GNC-035 in Phase I, determining the appropriate dose levels and recommended dose for Phase II. Phase II focuses on exploring the drugs effectiveness in this patient population to better understand its potential benefits. Participants receive GNC-035 through an intravenous infusion lasting 2 to 4 hours, given once a week in cycles of three weeks. Those who benefit from the treatment may continue receiving additional cycles. Treatment will stop if the disease progresses, side effects become intolerable, or other reasons occur. The study is open-label and multicenter, with no placebo or blinding. During the trial, participants will be closely monitored for dose limiting toxicities, treatment side effects, and response to the drug using criteria such as objective response rate and progression-free survival. Various laboratory tests and assessments will be conducted up to 24 months after the first dose to evaluate safety, pharmacokinetics, and anti-tumor activity. Participants must comply with scheduled visits and procedures throughout the study period, which could last up to two years or more depending on treatment continuation.

A Study of GNC-035 in Relapsed or Refractory Non-Hodgkin 's Lymphoma and Other Hematological Malignancies