NCT05944978

A Study of GNC-035 in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematological Malignancies

Phase Ib/II Clinical Study of GNC-035 Tetra-specific Antibody Injection in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematological Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label, multicenter, phase Ib/II clinical trial was conducted to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of GNC-035 quad-specific antibody injection in patients with relapsed or refractory chronic lymphocytic leukemia and other hematological malignancies

Detailed description

Phase Ib: To observe the safety and tolerability of GNC-035 in patients with hematologic malignancies such as relapsed/refractory chronic lymphocytic leukemia, and to determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD), or maximum dose if MTD is not reached (MAD), of GNC-035. To determine the recommended phase II dose (RP2D) in hematologic malignancies such as chronic lymphocytic leukemia. Phase II: To explore the efficacy of GNC-035 in patients with relapsed/refractory chronic lymphocytic leukemia and other hematological malignancies.

Conditions

• Relapsed/Refractory Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	GNC-035	GNC-035 was intravenously infused 2h to 4h, once a week (IV, QW), and a 3-week cycle was used.

Timeline

• Start date: 2023-08-16
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2023-07-14
• Last updated: 2025-09-26

Locations

1 site across 1 country: China