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Classical Hodgkin's LymphomaPhase 2NCT03655483

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

A Phase 2 study testing GLS-010 in people with Classical Hodgkin's Lymphoma, run by Guangzhou Gloria Biosciences Co., Ltd. at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Patients with refractory cHL. Patients will be treated with GLS-010 Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Classical Hodgkin's Lymphoma
What is being tested?
GLS-010
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
5 sitesChina
Study dates
24 Aug 2018to 11 Apr 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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
  • Serum total bilirubin ≤ 1.5 X ULN
  • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
  • Serum creatinine OR ≤1.5 X upper limit of normal (ULN)
  • International Normalized Ratio (INR) or Prothrombin Time (PT)≤1.5 X ULN unless subject is receiving anticoagulant therapy, then as long as coagulation parameter (PT /INR or Activated Partial Thromboplastin Time (aPTT) , or anti-Xa factor )is within therapeutic range of intended use of anticoagulants.
  • Since signing the ICF, female or male subjects of childbearing potential should be willing to use an adequate method of contraception with the spouse for the course of the study through 5 months after the last dose of study medication.

Who cannot join

  • 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.
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  • 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.)
  • History of allergic reactions attributed to any macromolecular protein preparation/monoclonal antibody, or any other composition of the study drug.
  • Investigational drug therapy outside of this trial during or within 4 weeks prior to GLS-010.
  • Has had prior chemotherapy, radiation therapy, targeted small molecule therapy or major surgery within 4 weeks prior to the first dose of study drug; who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent (alopecia excluded)
  • Has history of Interstitial Lung Disease or non-infectious pneumonitis (Patients caused by radiotherapy are eligible.)
  • Has history of alcoholism or drug abuse within 1 year;
  • Has clear history of neurological or mental disorders, i.e. epilepsy, dementia, and poor compliance.
  • Has received an anti-infection vaccine within 4 weeks prior to the first dose of study drug (i.e. Influenza virus vaccines, HPV vaccines). Any live vaccines are not allowed during the study.
  • Pregnancy or lactation.
  • Other conditions that do not permit compliance with the protocol, evaluated by the investigator.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Peking University Cancer Hospital & Institute

    Beijing

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

  • Guizhou Cancer Hospital

    Guiyang, Guizhou

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

Other trials in China

About this study

Official title: A Single Arm，Multicenter， Phase II Clinical Study to Evaluate the Efficacy and Safety of GLS-010 Injection in the Treatment of Recurrent or Refractory Classical Hodgkin's Lymphoma

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

Read the detailed description

Open, uncontrolled, multi-center, phase II study.

Being tested
GLS-010

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GLS-010Drug

    Also called Full-human anti-pd-1 monoclonal antibodies

    Full-human anti-pd-1 monoclonal antibodies

Study groups in NCT03655483
Study groupRoleWhat they receive
GLS-010ExperimentalGLS-010
Receives: Drug: GLS-010

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

    Based on an independent image assessment board

    Measured: 2 months

Secondary outcomes (5)

  1. PFS

    meaningful benefit in PFS based on Lugano 2014

    Measured: 8 weeks

  2. OS

    Overall survival

    Measured: within 3 years of last patient enrolled

  3. DCR

    meaningful benefit in DCR based on Lugano 2014

    Measured: 8 weeks

  4. DOR

    meaningful benefit in DOR based on Lugano 2014

    Measured: 8 weeks

  5. TTR

    meaningful benefit in TTR based on Lugano 2014

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2018
  2. Study start24 Aug 2018
  3. Primary completion11 Apr 2021 (estimated)
  4. Study completion11 Apr 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03655483
Sponsor's protocol ID
YH-S001-04
Status last verified
Jun 2020
First submitted
28 Aug 2018
Last updated
11 Jun 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39799811

  • 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.

    PubMed 34462189

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GLS-010 in people with Classical Hodgkin's Lymphoma, run by Guangzhou Gloria Biosciences Co., Ltd. at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03655483, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.

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