A Study of Zimberelimab(GLS-010) Combined With AVD for Newly Diagnosed Early-stage Hodgkin's Lymphoma

• Status: Recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a multicenter, open-label single-arm phase II study to evaluate the efficacy and safety of Zimberelimab (GLS-010) combined with AVD for newly diagnosed early-stage Hodgkin's lymphoma under the guidance of PET/CT.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborator: Guangzhou Gloria Biosciences Co., Ltd.

Criteria

Inclusion Criteria:

1. Diagnosed with primary classical Hodgkin lymphoma (HL) based on histopathology.

2. Stage I-II .

3. At least one measurable target lesion（Lugano 2014）.

4. Age 18 years or older (including 18 years) to 45 years (recent fertility requirements and concern about chemotherapy side effects), or age >60 years (older patients who are frail and unwilling to undergo chemotherapy), male or female.

5. ECOG PS 0-3,

6. Expected survival ≥ 3 months.

Exclusion Criteria:

1. Hodgkin's lymphoma with nodular lymphocyte predominant type.

2. Patients who are scheduled to undergo subsequent autologous stem cell transplantation.

3. Contraindications to radiotherapy.

4. With central nervous system (meningeal or parenchymal) involvement.

5. Contraindications to immune checkpoint inhibitors.