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Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2NCT07480850

Efficacy and Safety of Glofitamab Combined With GemOxin the Treatment of Refractory Diffuse Large B-Cell Lymphoma

A Phase 2 study testing Glofitamab, Gemcitabin and Oxaliplatin in people with Refractory Diffuse Large B-Cell Lymphoma (DLBCL), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

In patients with relapsed or refractory diffuse DLBCL who have not achieved complete remission in the mid-term, the treatment with Glofit+GemOx regimen is used. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Glofitamab, Gemcitabin and Oxaliplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
1 Jan 2026to 2 Jan 2028
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years;
  • DLBCL confirmed by pathological diagnosis according to the WHO 2016 classification;
  • PET-positive (Deauville score 4-5) according to Lugano response criteria after 3 cycles of first-line treatment;
  • No history or evidence of central nervous system involvement;
  • Adverse reactions from prior treatments have recovered to grade 1 or below (excluding clinically insignificant reactions such as hair loss);
  • ECOG performance status score ≤ 2;
  • Adequate bone marrow, kidney, liver, respiratory, and cardiac function: absolute neutrophil count ≥ 1000/μL; platelet count ≥ 75,000/μL; absolute lymphocyte count ≥ 100/μL; creatinine clearance ≥ 60 mL/min; ALT and AST ≤ 2.5 times the upper limit of normal; total bilirubin ≤ 1.5 mg/dL (except for Gilbert's syndrome); cardiac echocardiography showing ejection fraction ≥ 50% with no pericardial effusion (small or physiological effusions excluded); no clinically significant serosal effusions; baseline oxygen saturation > 92%;
  • The subject is able to understand the study protocol, is willing to participate in this study, and provides written informed consent.

Who cannot join

  • History of malignant tumors, excluding non-melanoma skin cancers or carcinoma in situ (cervix, bladder, breast), unless the disease has been in remission for at least 3 years;
  • Uncontrolled fungal, bacterial, viral, or other infections requiring intravenous anti-infective therapy;
  • Human immunodeficiency virus (HIV) infection, or acute/chronic active hepatitis B or C infection;
  • Malignant cells detectable in cerebrospinal fluid or active CNS lymphoma;
  • History of myocardial infarction, coronary artery bypass graft, or stent implantation within 12 months prior to enrollment;
  • History of deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment;
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  • Female patients who are pregnant or breastfeeding, as determined by the investigator;
  • Inability of the subject to complete the study protocol or visits;
  • Presence of uncontrollable infection;
  • Currently participating in interventional study treatment, or having received other investigational drugs within 4 weeks prior to first dose (previous treatment with cetuximab, oxaliplatin, and gemcitabine is included);
  • Any other condition that the investigator deems the patient unsuitable for this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, beijing,

    Beijing

Other trials in China

About this study

Official title: Efficacy and Safety of Glofitamab Combined With GemOx (Gemcitabine and Oxaliplatin) in the Treatment of Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Multicenter, Single-Arm, Phase II Study

In patients with relapsed or refractory diffuse DLBCL who have not achieved complete remission in the mid-term, the treatment with Glofit+GemOx regimen is used.

Read the detailed description

Efficacy and Safety of Glofitamab Combined with GemOx (Gemcitabine and Oxaliplatin) in the Treatment of Refractory Diffuse Large B-Cell Lymphoma.

Being tested
Glofitamab, Gemcitabin, Oxaliplatin, Obinutuzumab
Medical subject headings
Lymphoma, Large B-Cell, Diffuse

What participants receive

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

  • GlofitamabDrug

    Also called Glofit

    On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.

  • GemcitabinDrug

    Also called Gem

    On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.

  • OxaliplatinDrug

    Also called Ox

    On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.

  • ObinutuzumabDrug

    Also called G

    On Day 1 of Cycle 1 (7 days before the first administration of Glofitamab), a single intravenous dose of 1000 mg of Obinutuzumab was administered. Then, in Cycle 1 (Day 8: 2.5 mg; Day 15: 10 mg), Glofitamab was administered intravenously with gradually increasing doses, followed by a fixed dose of 30 mg of Glofitamab on Day 1 of Cycles 2 to 6. GemOx treatment (intravenous Gemcitabine 1000 mg/m² and Oxaliplatin 100 mg/m², administered on Day 2 of Cycle 1 and then on Day 1 of subsequent cycles) was given every 21 days per cycle.

Study groups in NCT07480850
Study groupRoleWhat they receive
Refractory diffuse large B-cell lymphomaExperimental1）. Age ≥18 years; 2）. DLBCL confirmed by WHO 2016 pathological classification; 3）. After 3 cycles of first-line treatment, PET-positive according to Lugano response criteria (Deauville score 4-5); 4）. No history or evidence of central nervous system involvement;
Receives: Drug: Glofitamab; Drug: Gemcitabin; Drug: Oxaliplatin; Drug: Obinutuzumab

What is being measured

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

  1. Complete Response Rate

    Refers to the proportion of patients whose all detectable target lesions (such as tumor lesions or affected tissues) have completely disappeared after treatment with Glofitamab combined with GemOx, and this state lasts for at least 4 weeks. This condition needs to be confirmed through imaging examinations (such as CT, MRI, or PET-CT) and assessed comprehensively in combination with ctDNA.

    Measured: From enrollment to the end of treatment at 8 weeks

Secondary outcomes (4)

  1. ORR

    The overall response rate (ORR) was defined as the cumulative proportion of patients attaining either a complete response (CR) or partial response (PR) .

    Measured: From enrollment to the end of treatment at 8 weeks

  2. OS

    OS was measured from Golfitamab combined with GemOx initiation to death or last follow-up

    Measured: From enrollment to the end of treatment at 8 weeks

  3. PFS

    PFS defined as the time from Glofitamab combined with GemOx initiation to first documented disease progression, relapse after Glofitamab combined with GemOx, death from any cause, or last follow-up.

    Measured: From enrollment to the end of treatment at 8 weeks

  4. DoR

    It refers to the period of time from when a patient first achieves disease remission (such as tumor shrinkage reaching a certain percentage or significant improvement in symptoms) after receiving treatment, until the disease progresses again, relapses, or related adverse events (such as death) occur.

    Measured: From enrollment to the end of treatment at 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 posted18 Mar 2026
  2. Study start1 Jan 2026
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion2 Jan 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 2
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
NCT07480850
Sponsor's protocol ID
NCCH0050
Status last verified
Feb 2026
First submitted
14 Mar 2026
Last updated
18 Mar 2026
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 2 study testing Glofitamab, Gemcitabin and Oxaliplatin in people with Refractory Diffuse Large B-Cell Lymphoma (DLBCL), run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. 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 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?

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?

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?

Complete Response Rate (time frame: From enrollment to the end of treatment at 8 weeks). 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 NCT07480850.

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 18 Mar 2026.

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