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

Refractory Classic Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05518318
• Other study ID #: GLS-010-31
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2022
• Est. completion date: June 2025

Study information

• Verified date: August 2022
• Source: Guangzhou Gloria Biosciences Co., Ltd.
• Contact: ting lu
• Phone: 0086-10-88196391
• Email: luting_1010[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Classic Hodgkin's Lymphoma
• Hodgkin Disease
• Lymphoma
• Recurrent Classic Hodgkin Lymphoma
• Refractory Classic Hodgkin Lymphoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Gloria Biosciences Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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