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

Evaluate the Efficacy and Safety of GLS-010 Versus Chemotherapy Assessed by Investigator in Patients With Relapsed or Refractory Classical Hodgkin's Lymphoma (R/R cHL) in a Randomized, Open, Multicenter Phase III Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Recurrent Classic Hodgkin Lymphoma; Refractory Classic Hodgkin Lymphoma; Classic Hodgkin's Lymphoma
• Intervention / Treatment: Drug: GLS-010; Drug: Chemotherapy of Investigator's choice

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ting lu; Phone Number: 0086-10-88196391; Email: luting_1010@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GLS-010; GLS-010 therapy	Drug: GLS-010; Participants receive GLS-010 240mg intravenously (IV) on Day 1, Q2W; Other Names: GLS-010 therapy
ACTIVE_COMPARATOR: chemotherapy	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS)	Defined as the time from the date of randomization to the date of death due to any Defined as the time from the date of randomization to the date of death due to any reason	Up to 2 years
Objective Response Rate (ORR)	ORR defined as the proportion of subjects who achieves a best overall response of CR or PR based on Lugano 2014 classification.	Up to 2 years
Disease Control Rate (DCR)	DCR defined as the proportion of subjects' response of CR, PR, or SD based on Lugano Classification 2014.	Up to 2 years
Duration of Response (DoR)	Up to 2 years	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)	Up to 2 years	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events (AEs)	Up to 2 years	From the time of signed informed consent through 90 days after the last dose of GLS-010

Collaborators and Investigators

• Sponsor: Guangzhou Gloria Biosciences Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): June 1, 2025
• Study Completion (ANTICIPATED): June 1, 2025

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (ACTUAL): August 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: GLS-010; relapsed or refractory classic Hodgkin's lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease
• Other Study ID Numbers: GLS-010-31

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No