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

Guangzhou Gloria Biosciences

Status and phase: Not yet enrolling; Phase 3

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

Treatments: Drug: Chemotherapy of Investigator's choice; Drug: GLS-010

Study type: Interventional

Funder types: Industry

Identifiers

NCT05518318

GLS-010-31

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

GLS-010

Experimental group

Description:

GLS-010 therapy

Treatment:

Drug: GLS-010

chemotherapy

Active Comparator group

Description:

chemotherapy

Treatment:

Drug: Chemotherapy of Investigator's choice