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.
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.
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
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.
- Conditions
- B Cell Lymphoma (BCL)
- 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 group | Role | What they receive |
|---|---|---|
| Experimental: Glofitamab treatment | Experimental | Not described Receives: Biological: Glofitamab treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted2 May 2025
- Study start30 May 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell Lymphoma (BCL)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Zhengzhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mingzhi Zhang, Zhengzhou University
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
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Glofitamab for Consolidation After First-line Treatment of High-risk Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT06956092
- Acronym / sponsor ID
- Glofitamab / 2025-IIT-0013
- Conditions
- B Cell Lymphoma (BCL)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhengzhou UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Glofitamab treatment | Experimental | Biological: Glofitamab treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (33 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glofitamab treatmenteceive Glofitamab treatment as per the instructions in the package insert. | Biological | Experimental: Glofitamab treatment |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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?
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; AzTrials last refreshed its copy on 8 Nov 2026.