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

NCT03655483 | Unknown Phase 2

• 1 other identifier: YH-S001-04
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 5

Brief Summary

Patients with refractory cHL. Patients will be treated with GLS-010

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-010 DRUG

Full-human anti-pd-1 monoclonal antibodies

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

GLS-010

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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;
• Male or female, Age between 18 and 70 years old (margin included) on the day of signing informed consent.
• Histologically confirmed diagnosis of cHL(classical Hodgkin Lymphoma);
• Relapsed or refractory classical Hodgkin Lymphoma patients after 2 or more lines of therapies( Relapsed cHL patients are defined as patients with new lesion found at primary site or other sites after achieving a complete response after the last treatment; refractory cHL is defined as patients achieve a less than complete response or partial response after the last treatment）and at least one of the following condition is in accordance with:
• Participant has failed to achieve a response after treatment with autologous stem cell transplant (auto-SCT) or relapsed after achieving a response.
• Participant has failed to achieve a response to, progressed after, or be ineligible for autologous stem cell transplant (auto-SCT)
• Based on Lugano 2014, at least one bi-dimensional measurable Lymph node lesion with minimum measurement of \> 15 mm or an extranodal lesion with minimum measurement of \> 10 mm in the longest diameter of cross-sectional areas in CT test, plus positive on Fluorodeoxyglucose-positron tomography（FDG-PET）.
• Paraffin embedding sample or biopsy sample available during screening;
• Must have ECOG performance status of 0 or 1
• Has a predicted survival period ≥ 12 weeks;
• Demonstrate adequate organ and hematopoietic function as defined below:
• Hemoglobin ≥8.0 g/dL
• Absolute neutrophil count (ANC) ≥1000 /mcL
• Platelets ≥75,000 / mcL

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.)

Sponsors & Collaborators

• Guangzhou Gloria Biosciences Co., Ltd.: lead

Study Sites (5)

Guizhou Cancer Hospital

Guiyang, Guizhou, China

Location

Hunan Cancer Hospital

Changsha, Hunan, China

Location

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Location

Peking University Cancer Hospital & Institute

Beijing, China

Location

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: 39799811 DERIVED

• 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 DERIVED

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
• Primary Completion: April 11, 2021
• Study Completion: April 11, 2022
• Last Updated: June 11, 2020

Record last verified: 2020-06

Locations

CN (5)