Trials Sponsors Conditions Drugs Pricing

Conditions

Classical Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

Objective response rate
Based on an independent image assessment board
2 months

Secondary Outcomes (5)

PFS
8 weeks
OS
within 3 years of last patient enrolled
DCR
8 weeks
DOR
8 weeks
TTR
8 weeks

Study Arms (1)

GLS-010

EXPERIMENTAL

GLS-010

Drug: GLS-010

Interventions

GLS-010Drug

Full-human anti-pd-1 monoclonal antibodies

Also known as: Full-human anti-pd-1 monoclonal antibodies

GLS-010

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects who met all the criteria below could be selected for the study:
Willingness to participate in the clinical trial. Provide written informed consent prior to any study-specific screening procedures. Willingness and capability to comply with the requirements of the study;

Sponsors & Collaborators

Guangzhou Gloria Biosciences Co., Ltd.
Industrylead

Study Sites (5)

Guizhou Cancer Hospital

Guiyang, Guizhou, China

Hunan Cancer Hospital

Changsha, Hunan, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Peking University Cancer Hospital & Institute

Beijing, China

Related Publications (2)

Kan S, Bai H, Liu H, Cui J, Ke X, Zhang H, Liu L, Yan D, Jiang Y, Zang A, Qi J, Wang L, Liu Z, Xu B, Zhang Y, Zhang Z, Zhao X, Hu C, Yang S, Zhou H, Shi J, Shao Z, Xiang Y, Lin N, Zhang M. Long-term follow-up of zimberelimab in relapsed or refractory classic Hodgkin lymphoma: Insights from the phase Ⅱ YH-S001-04 clinical trial. Leuk Res. 2025 Feb;149:107633. doi: 10.1016/j.leukres.2024.107633. Epub 2024 Nov 26.
PMID: 39799811DERIVED
Lin N, Zhang M, Bai H, Liu H, Cui J, Ke X, Zhang H, Liu L, Yan D, Jiang Y, Zang A, Qi J, Wang L, Liu Z, Xu B, Zhang Y, Zhang Z, Zhao X, Hu C, Yang S, Zhou H, Shi J, Shao Z, Xiang Y, Zhu J, Song Y, Zhu J. Efficacy and safety of GLS-010 (zimberelimab) in patients with relapsed or refractory classical Hodgkin lymphoma: A multicenter, single-arm, phase II study. Eur J Cancer. 2022 Mar;164:117-126. doi: 10.1016/j.ejca.2021.07.021. Epub 2021 Aug 27.
PMID: 34462189

MeSH Terms

Interventions

zimberelimab

Study Officials

Jun Zhu, MD
Peking University Cancer Hospital & Institute
PRINCIPAL INVESTIGATOR
Yuqin Song, MD
Peking University Cancer Hospital & Institute
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 28, 2018

First Posted

August 31, 2018

Study Start

August 24, 2018

Actual (reported)

Primary Completion

April 11, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

You may not qualify if:

Subjects who met the following criteria were not eligible for the study:
Nodular lymphocytes is confirmed as primary Hodgkin lymphoma or grey zone lymphoma.
Has known active central nervous system (CNS) metastases.
Has undergone allogeneic hematopoietic stem cell transplantation.
Has undergone autologous stem cell transplantation within 100 days prior to the first dose of study drug.
Grade 3 or 4 congestive heart failure (New York Heart Association (NYHA)), unstable angina pectoris, poorly controlled arrhythmias(including male QTc intervals≥ 450 ms, female QTc intervals≥ 470 ms, QTc intervals calculated by Formula Fridericia), acute ischemia on ECG or myocardial infarction within 6 months prior to screening.
Patients with any autoimmune disease, i.e., but not limited to, interstitial pneumonia, uveitis, enteritis,hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (hypothyroidism without clinical symptoms or caused by radiotherapy and chemotherapy can be included); Patients with vitiligo or asthma CR in Childhood, not requiring any intervention in adulthood are permitted to enroll.; patients with asthma requiring a bronchiectasis intervention are not permitted to enroll.
Subjects that requires systemic corticosteroids (Dose equivalent to or above 10 mg prednisone daily) or other immunosuppressive medications;
Has received a live anti-tumor vaccine, or anti-tumor treatment with immunostimulation within 4 weeks prior to pre-screening.
Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti CTLA-4 antibody (including Ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
Presence of other active cancers within 5 years prior to enrollment. Patients with cervical carcinoma in situ/ cured skin basal cell carcinoma who have received definitive adequate treatment are eligible.
Participants with active viral hepatitis (positive HepB sAg and/or positive HepB core Ab with positive HepB DNA\> 103copies/mL, or positive HepC antibody), or syphilis positive.
Has a known Human Immunodeficiency Virus (HIV) infection, or other acquired and congenital immune deficiency diseases, or history of organ transplant.
Has history of active TB infection within 1 year prior to enrollment. (Suspected TB infection patient needs chest X-ray, sputum examination and clinical symptom for conformation. Patients with active TB infection should be excluded even if cured.)
Subject that requires systematic treatment for active infection, unexplained fever\> 38.5°C prior to the first dose of study drug during screening( Subjects that has tumor related fever could be included while confirmed by the investigator.)
+9 more criteria

Study of GLS-010 Injection in the Treatment of Classical Hodgkin's Lymphoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

GLS-010

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (2)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

GLS-010

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

Related Publications (2)

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations