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

NCT05518318 | Unknown Phase 3 DMC

• 1 other identifier: GLS-010-31
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Keywords

GLS-010; relapsed or refractory classic Hodgkin's lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) assessed by Independent Radiologic Review Committee (IRRC) per Lugano Classification 2014

  Time from the date of randomization to the date of progressive disease (PD) or death, whichever occurs first.

  Up to 2 years

Secondary Outcomes (5)

• Overall Survival (OS)

  Up to 2 years

• Objective Response Rate (ORR)

  Up to 2 years

• Disease Control Rate (DCR)

  Up to 2 years

• Duration of Response (DoR)

  DoR defined as the time from the date that CR or PR are first occurred to the date of objective disease progression or death, whichever occurs first

• Time to Response (TTR)

  TTR defined as the time from the date of randomization to the date when the response criteria are first met, based on Lugano Classification 2014

Other Outcomes (1)

• Number of subjects with adverse events (AEs)

  From the time of signed informed consent through 90 days after the last dose of GLS-010

Study Arms (2)

GLS-010

EXPERIMENTAL

GLS-010 therapy

Drug: GLS-010

chemotherapy

ACTIVE COMPARATOR

chemotherapy

Drug: Chemotherapy of Investigator's choice

Interventions

GLS-010 DRUG

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

Also known as: GLS-010 therapy

GLS-010

Chemotherapy of Investigator's choice 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

chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent form (ICF).
• Age of ≥ 18 years at the time of enrollment.
• Histologically confirmed classic Hodgkin's lymphoma (cHL).
• Subjects required Relapsed or refractory ,failure to at least 2 lines of prior systemic chemotherapy.
• Patients who have failed prior vibutuximab treatment or are unwilling or not eligible for vibutuximab treatment
• Have at least one measurable lesion according to Lugano classification 2014 and FDG-PET was positive.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy of ≥ 12 weeks.
• Have adequate hematologic and organ function .

You may not qualify if:

• Nodular lymphocytes are non-Hodgkin's lymphoma or gray area lymphoma.
• Central nervous system lymphoma invasion.
• Subjects requiring systemic corticosteroids or other immunosuppressive agents within 14 days prior to screening or during the study period.
• 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.
• Known human immunodeficiency virus (HIV), or serologic status reflecting active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• 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.
• 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).
• Pregnant or breast-feeding women.
• Patients are unsuitable for the study evaluated by investigator.

Sponsors & Collaborators

• Guangzhou Gloria Biosciences Co., Ltd.: lead

MeSH Terms

Conditions

Recurrence

Interventions

zimberelimab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ting lu

CONTACT

0086-10-88196391; luting_1010@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 26, 2022
• Study Start: September 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: August 26, 2022

Record last verified: 2022-08