GLS-010 Monotherapy Versus Chemotherapy in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL)

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the efficacy of GLS-010 in participants with relapsed or refractory classical Hodgkin lymphoma (R/R cHL), as measured by Progression-free Survival (PFS) as assessed by IRRC

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guangzhou Gloria Biosciences Co., Ltd.

Criteria

Key Inclusion Criteria:

1. Signed written informed consent form (ICF).

2. Age of ≥ 18 years at the time of enrollment.

3. Histologically confirmed classic Hodgkin's lymphoma (cHL).

4. Subjects required Relapsed or refractory ,failure to at least 2 lines of prior systemic chemotherapy.

5. Patients who have failed prior vibutuximab treatment or are unwilling or not eligible for vibutuximab treatment

6. Have at least one measurable lesion according to Lugano classification 2014 and FDG-PET was positive.

7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

8. Life expectancy of ≥ 12 weeks.

9. Have adequate hematologic and organ function .

Key Exclusion Criteria:

1. Nodular lymphocytes are non-Hodgkin's lymphoma or gray area lymphoma.

2. Central nervous system lymphoma invasion.

3. Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days prior to screening or during the study period.

4. Prior exposure to any anti-PD-1, anti-PD-L1,anti-PD-L2, anti-CD137,anti-CTLA-4 antibody, or any other antibody or drug target for T cell co-stimulatory or checkpoint pathways.

5. Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

6. Subjects with other malignancy within 5 years prior to the first dose of study treatment, except for Cervical carcinoma in situ and Cured basal cell carcinoma of the skin.

7. Have received chemotherapy, radiotherapy, molecular-targeted therapy or major surgery within 4 weeks prior to the first dose of study treatmen; Clinically significant AE associated with previous treatment has not returned to baseline or ≤1 (except hair loss).

8. Pregnant or breast-feeding women.

9. Patients are unsuitable for the study evaluated by investigator.