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

NCT ID: NCT05518318

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2025-06-30

Brief 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

Conditions

Classic Hodgkin's Lymphoma; Recurrent Classic Hodgkin Lymphoma; Refractory Classic Hodgkin Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GLS-010

GLS-010 therapy

Group Type: EXPERIMENTAL

GLS-010

Intervention Type: DRUG

Participants receive GLS-010 240mg intravenously (IV) on Day 1, Q2W

chemotherapy

chemotherapy

Group Type: ACTIVE_COMPARATOR

Chemotherapy of Investigator's choice

Intervention Type: DRUG

Chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP,GEMOX, ESHAP , ICE , IGEV and GVD

Interventions

GLS-010

Participants receive GLS-010 240mg intravenously (IV) on Day 1, Q2W

Intervention Type: DRUG

Chemotherapy of Investigator's choice

Chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP,GEMOX, ESHAP , ICE , IGEV and GVD

Intervention Type: DRUG

Other Intervention Names

GLS-010 therapy

Eligibility Criteria

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 .

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Gloria Biosciences Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

ting lu

Role: CONTACT

luting_1010@163.com

0086-10-88196391

Other Identifiers

GLS-010-31

Identifier Type: -

Identifier Source: org_study_id