NCT05485753

A Study of GNC-038, a Tetra-specific Antibody, in Patients With Central Nervous System Lymphoma (PCNSL) and Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL)

An Open, Multicenter, Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed or Refractory Secondary Central Nervous System Lymphoma (SCNSL)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

In this study, the safety and preliminary efficacy of GNC-038 in patients with r relapsed or refractory primary central nervous system lymphoma (PCNSL) and relapsed or refractory secondary central nervous system lymphoma (SCNSL) will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-038. The recommended dose for phase II (RP2D) clinical study will also be determined.

Conditions

• Primary Central Nervous System Lymphoma
• Secondary Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	GNC-038	Administration by intravenous infusion

Timeline

• Start date: 2023-02-10
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-08-03
• Last updated: 2025-09-26

Locations

4 sites across 1 country: China