Study of GNC-038 Injection Given by IV to Treat Adults with Relapsed or Refractory Non-Hodgkins Lymphoma Evaluating Safety, Tolerability, and Effectiveness in Phase IbII

What this Trial Is About

Researchers are studying the safety and early effects of GNC-038, a tetra-specific antibody, in patients with relapsed or refractory non-Hodgkins lymphoma NHL. The study aims to find the highest safe dose and recommended phase II dose, or the maximum administered dose and dose-limiting toxicities if the highest safe dose is not reached. This open, multicenter trial includes both phase Ib and phase II parts to evaluate tolerability, pharmacokinetics, and antitumor activity of GNC-038. Participants receive GNC-038 through intravenous infusion once a week, with cycles lasting two weeks. After the first cycle, those who benefit clinically may continue treatment for additional cycles until disease progression, intolerable side effects, or other reasons lead to stopping treatment. The study includes a dose escalation phase followed by an efficacy evaluation phase. Throughout the study, patients undergo evaluations for dose-limiting toxicities, maximum tolerated or administered dose, and adverse events up to about 24 months. Researchers also measure disease control rate, progression-free survival, pharmacokinetics, and immune response to the drug. Ongoing assessments include regular visits, laboratory tests, and monitoring for safety and treatment response during and after treatment.

A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma