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B Cell Lymphoma (BCL)Phase 4GlofitamabNCT06956092

Glofitamab for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma

A Phase 4 study testing Glofitamab treatment in people with B Cell Lymphoma (BCL), run by Zhengzhou University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if Glofitamab works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of Glofitamab treatment. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
B Cell Lymphoma (BCL)
What is being tested?
Glofitamab treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
30 May 2025to Dec 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understand and voluntarily sign the informed consent form.
  • Age 18-75 years (inclusive, including 18 and 75 years) at screening; no restriction on gender.
  • Diagnosed with B-cell non-Hodgkin lymphoma according to the 2022 WHO Classification of Tumors of Hematopoietic and Lymphoid Tissues (5th edition). The following subtypes are included in this trial:
  • 1) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), defined as high-risk disease meeting at least one of the following criteria: IPI score of 4-5 at initial diagnosis, TP53 negativity or overexpression (>50%) or TP53 mutation identified by gene sequencing, MYC rearrangement, CD5(+), MYC and BCL2 co-expression.
  • 2) Follicular lymphoma-transformed large B-cell lymphoma. 3) High-grade B-cell lymphoma (HGBL) with MYC and BCL2 rearrangement. 4) High-grade B-cell lymphoma, not otherwise specified (HGBL-NOS). 5) Intravascular large B-cell lymphoma. 6) Large tumor mass (≥7.5 cm). 4. Histopathologically and/or cytologically confirmed CD20-positive large B-cell lymphoma patients who have achieved CR, Cru, or VGPR after prior first-line treatment with rituximab-containing chemoimmunotherapy.
  • 5. Expected survival ≥12 weeks. 6. Target lesion defined as a lymph node-based lesion with a long diameter ≥15 mm or an extranodal lesion >10 mm (according to Lugano 2014 criteria); lesions previously treated with radiotherapy must show clear progression post-radiation to be considered measurable.
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  • 7. Patients with occult or early-stage hepatitis B infection (defined as HBcAb positive and HBsAg negative) are eligible for inclusion if HBV DNA PCR testing is negative. These patients will undergo monthly HBV DNA PCR monitoring. Patients seropositive for HCV antibodies are eligible if HCV RNA PCR testing is negative.
  • 8. Adequate bone marrow reserve, defined as: neutrophil count ≥1.0×10^9/L; lymphocyte count ≥0.2×10^9/L; hemoglobin >80 g/L; platelets >80×10^9/L.
  • 9. Non-hematologic toxicities caused by prior treatments (excluding disease-related conditions) must have resolved to ≤Grade 1 prior to enrollment (except alopecia and chemotherapy-induced Grade ≥2 neurotoxicity).
  • 10. Appropriate organ function, meeting the following criteria (excluding abnormalities caused by tumor infiltration):
  • Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); alanine aminotransferase (ALT) ≤3 times ULN; total serum bilirubin ≤2 times ULN, unless Gilbert syndrome is present. Patients with Gilbert syndrome can be included if total bilirubin ≤3 times ULN and direct bilirubin ≤1.5 times ULN.
  • Serum creatinine ≤1.5 times ULN or creatinine clearance ≥60 mL/min (using Cockcroft-Gault formula: Male CrCl = [(140-age) × weight (kg)] / [0.818 × creatinine (μmol/L)]; Female CrCl = [(140-age) × weight (kg) × 0.85] / [0.818 × creatinine (μmol/L)]).
  • Minimum pulmonary reserve: ≤Grade 1 dyspnea (CTCAE v5.0) and oxygen saturation ≥92% under non-oxygenated conditions.
  • Left ventricular ejection fraction (LVEF) ≥50% by echocardiography; no clinically significant ECG abnormalities; no clinically significant pericardial effusion or pleural effusion.
  • International normalized ratio (INR) ≤1.5 times ULN and activated partial thromboplastin time (APTT) ≤1.5 times ULN.
  • 11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 12. No central nervous system lymphoma determined by cranial MRI. 13. Women of childbearing potential must have a negative blood/urine pregnancy test within 7 days prior to infusion. All male and female patients capable of reproduction must agree to use effective contraception throughout the study and for at least 2 years after study treatment administration. A patient is deemed capable of reproduction based on their biological ability to conceive and normal sexual activity, as judged by the investigator. Women are deemed incapable of reproduction if they meet at least one of the following criteria: medically-confirmed ovarian failure, hysterectomy, bilateral oophorectomy, or post-menopausal status (defined as cessation of menstruation for at least 12 consecutive months).

Who cannot join

  • History of severe allergy or hypersensitivity reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins).
  • Received autologous hematopoietic stem cell transplantation (ASCT) within 100 days prior to the first dose of Glofitamab; received chimeric antigen receptor T-cell (CAR-T) therapy within 30 days prior to the first dose of Glofitamab.
  • Previously underwent allogeneic stem cell transplantation or allogeneic CAR-T therapy.
  • History of solid organ transplantation.
  • History of acute or chronic active hepatitis B or hepatitis C infection. Patients with a history of hepatitis must demonstrate viral clearance based on standard serological and genetic testing (i.e., hepatitis B surface antibody positive, other markers negative, and HBV DNA PCR negative) to be eligible; other cases require approval from the medical monitor.
  • Infection with human immunodeficiency virus (HIV).
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  • Known or suspected chronic active Epstein-Barr virus (CAEBV) infection.
  • Presence of uncontrolled bacterial, viral, fungal, mycobacterial, parasitic, or other infections (excluding nail bed fungal infections) at screening or occurrence of any serious infection within 4 weeks prior to the first infusion of Glofitamab (as judged by the investigator).
  • Current or history of central nervous system (CNS) disorders such as seizures, ischemic/hemorrhagic cerebrovascular events, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychiatric disorders, or autoimmune diseases involving the CNS.
  • History of autoimmune diseases, including but not limited to: myasthenia gravis, polymyositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome-associated vascular thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, glomerulonephritis, or active autoimmune cytopenias (autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP]).
  • Patients with long-standing or well-controlled autoimmune diseases may be eligible after discussion and confirmation with the investigator.
  • Patients with autoimmune thyroid dysfunction receiving stable doses of thyroid replacement hormone may be eligible.
  • Patients with well-controlled Type 1 diabetes (defined as fasting HbA1c <8% at screening and no ketoacidosis) are eligible.
  • Patients with skin-limited conditions such as eczema, psoriasis, chronic lichen simplex, or vitiligo may be eligible if the following criteria are met:
  • Rash involves <10% of body surface area.
  • Disease is well-controlled at baseline and requires only low-dose topical corticosteroids.
  • No exacerbations requiring treatment with psoralen plus UVA light, methotrexate, retinoids, biologics, oral calcineurin inhibitors, high-dose or systemic corticosteroids during the past 12 months.
  • Presence of primary or secondary active CNS lymphoma (patients with symptoms suggestive of CNS involvement must undergo lumbar puncture and MRI to exclude CNS lymphoma).
  • Prior receipt of other genetically modified T-cell therapy or CAR-T therapy.
  • Diagnosis of progressive multifocal leukoencephalopathy (PML).
  • Clinical emergencies requiring urgent intervention due to lymphoma-related obstruction or compression, such as intestinal obstruction or vascular compression, at screening.
  • Cardiac conditions meeting any of the following: left ventricular ejection fraction (LVEF) ≤45% (by echocardiography); New York Heart Association (NYHA) class III or IV congestive heart failure; severe arrhythmias requiring treatment, including QTc interval ≥450ms for males or ≥470ms for females (QTcB=QT/RR^1/2); uncontrolled hypertension (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg), pulmonary hypertension, or unstable angina; history of cardiac angioplasty or stent placement, myocardial infarction, unstable angina, or other clinically significant cardiac conditions within 12 months prior to administration; clinically significant valvular disease; lymphoma involving atrial or ventricular structures; or other cardiac diseases deemed unsuitable by the investigator.
  • Thromboembolic events (such as deep vein thrombosis or pulmonary embolism) within 6 months prior to screening.
  • Malignancies other than those indicated for this trial within 5 years prior to screening, except for melanoma, skin carcinoma, or in-situ cancers (e.g., cervical, bladder, breast carcinoma).
  • Receipt of live attenuated vaccines within 4 weeks prior to the first infusion of Glofitamab or expected need for such vaccines during the study period.
  • Major surgery within 4 weeks prior to the first infusion of Glofitamab. Protocol-required procedures such as tumor biopsy and bone marrow biopsy are allowed.
  • Systemic immunosuppressive therapy (including but not limited to azathioprine, methotrexate, thalidomide, or anti-TNF agents) within 2 weeks prior to the first infusion of Glofitamab. Corticosteroid therapy at ≤25 mg/day prednisone or equivalent is permitted.
  • Inhaled and topical corticosteroids are allowed.
  • Inability to comply with protocol-mandated hospitalization and activity restrictions.
  • Pregnant or breastfeeding women, or male or female patients of childbearing potential who refuse to use effective contraception during the study and for 2 years after the cellular infusion.
  • Participation in another interventional clinical trial, receipt of investigational drugs, or intent to enroll in another trial or receive non-protocol-defined antitumor therapy within 3 months before Glofitamab administration.
  • Any severe medical condition or laboratory abnormality, as determined by the investigator or medical monitor, that could compromise patient safety, adherence to the protocol, or interpretation of results.
  • Investigator deems the patient unsuitable for this trial (e.g., poor compliance, substance abuse, etc.).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Zhang, PhD contact

86-0371-66279567

fcczhangxd@zzu.edu.cn

China1 site

  • The First Affiliated Hospital of Zhengzhou University, Department of Oncology

    Zhengzhou, Henan, 450052

    Xudong Zhang, PhD, 86-0371-66279567, fcczhangxd@zzu.edu.cn

Other trials in China

About this study

Official title: Prospective Clinical Study of Glofitamab for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma

The goal of this clinical trial is to learn if Glofitamab works for consolidation after first-line treatment of high-risk Large B-cell Lymphoma (LBCL). It will also learn about the safety of Glofitamab treatment. The main questions it aims to answer are:

  • Does Glofitamab treatment result in prolonged clinical benefit to patients with high-risk LBCL after first-line treatment?
  • What medical problems do participants have when receiving Glofitamab treatment?

In this investigator-initiated, single-arm clinical trial, participants will:

  • Receive Glofitamab treatment as per the instructions in the package insert.
  • Visit the clinic as instructed for checkups and tests.
Being tested
Glofitamab treatment
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • Glofitamab treatmentBiological

    eceive Glofitamab treatment as per the instructions in the package insert.

Study groups in NCT06956092
Study groupRoleWhat they receive
Experimental: Glofitamab treatmentExperimentalNot described
Receives: Biological: Glofitamab treatment

What is being measured

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

  1. two year PFS

    Measured: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Timeline

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

  1. First posted2 May 2025
  2. Study start30 May 2025 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionDec 2028 (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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06956092
Sponsor's protocol ID
2025-IIT-0013
Acronym
Glofitamab
Status last verified
Apr 2025
First submitted
24 Apr 2025
Last updated
2 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Glofitamab treatment in people with B Cell Lymphoma (BCL), run by Zhengzhou University at 1 site 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 16 inclusion and 33 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: opening soon, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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

Contact Zhang, PhD (86-0371-66279567, fcczhangxd@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

two year PFS (time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 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 NCT06956092.

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 2 May 2025.

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