Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Phase 2GLOHRT-01NCT06867536
Hypofractionation Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse B-cell Lymphoma With Baseline High Tumor Burden
A Phase 2 study testing Glofitamab + Obinutuzumab in people with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Lymphoma, run by Liling Zhang at 1 site in China.
Trial summary
Glofitamab has shown efficacy and safety in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and has been approved for marketing in China. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL), Lymphoma
- What is being tested?
- Glofitamab + Obinutuzumab
- 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 Apr 2025to 31 Aug 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent.
- Aged 18-75 years at the time of signing the informed consent, willing to follow and able to complete all study procedures.
- Expected survival ≥ 12 weeks.
- ECOG performance status score of 0-2 points ;
- Patients with CD20-positive DLBCL confirmed by pathological histology; (unspecified DLBCL, HGBCL, PMBCL, FL-transformed DLBCL).
- R/R DLBCL who have received at least one line of systemic treatment (including at least 2 cycles of rituximab-containing immunochemotherapy).
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- Baseline high tumor burden, defined as tumor diameter > 6 cm and/or TMTV > 128.7 mL .
- HIV test results were negative at screening, except for the following: HIV-positive patients who have been receiving stable antiretroviral therapy and CD4 count ≥ 200/µL before enrollment Patients with undetectable viral load can be enrolled.
- Women of childbearing age with negative urine or blood pregnancy test within 7 days before enrollment need to agree to take effective contraceptive measures during treatment and follow-up.
Who cannot join
- Individuals who have drug allergies or metabolic disorders to the drugs in this protocol.
- Previous recipients of allogeneic organ transplants.
- Individuals who received systemic immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) of the drug.
- Anti-cancer drug treatment within 28 days before the start of treatment
- Prior radiotherapy in the mediastinum/pericardium area; radiation therapy for non-target lesion sites is allowed.
- History of severe or extensive cardiovascular disease.
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- Recent major surgery (within 4 weeks before the start of Cycle 1), excluding diagnostic surgeries.
- Currently suffering from active CNS lymphoma.
- Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- Current or previous history of concurrent Waldenström's macroglobulinemia.
- Known active infection at the time of enrollment in the study.
- Immune-related adverse events that appeared during prior immunotherapy: ≥Grade 3 adverse events, except for Grade 3 endocrine diseases controlled by alternative therapies. Grade 1 or 2 adverse events that did not return to baseline levels after stopping treatment.
- History of autoimmune diseases (long-standing or well-controlled autoimmune diseases, hypothyroidism, immune thrombocytopenic purpura, and well-controlled Type I diabetes are excluded).
- Abnormal coagulation function: INR or PT >1.5× upper limit of normal (ULN), PTT or aPTT >1.5× ULN.
- Suspected or latent tuberculosis (confirmed by positive IFNγ release test)
- Active hepatitis B virus (HBV) infection/positive HCV RNA test for hepatitis C virus (HCV)/HIV seropositive.
- Previously suffered from other invasive malignancies, excluding early-stage cervical cancer, basal cell carcinoma of the skin, and thyroid cancer .
- Pregnant or breastfeeding, or planning to become pregnant during the study period or within 18 months after pre-treatment with obinutuzumab or within 2 months after the last dose of glofitamab (whichever is longer).
- Other concurrent uncontrolled medical conditions that, in the investigator's opinion, would affect the patient's participation in the study.
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, 1 recruiting
- Recruiting
Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430022
About this study
Official title: A Prospective, Single Arm, Phase Ⅱ Study to Evaluate the Efficacy and Safety of Hypofractionation Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse B-cell Lymphoma With Baseline High Tumor Burden
Glofitamab has shown efficacy and safety in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and has been approved for marketing in China. However, in patients with baseline high tumor burden, the complete response (CR) rate is relatively lower compared with patients without. There is still a need to improve the efficacy of glofitamab in patients with high tumor burden. Previous studies have shown that hypofractionation radiotherapy (HRT) may induce T cell immune responses and improve the tumor microenvironment . Evidence shows that radiotherapy (RT) improves chimeric antigen receptor T-cell (CAR-T) efficacy as a bridging therapy . Based on the experience of RT combined with CAR-T, bispecific antibodies, as another T-cell therapy, may also demonstrate synergistic effects when combined with HRT, especially in those patients with bulky disease. This study will enroll R/R DLBCL patients with high tumor burden to assess the efficacy and safety of glofitamab in combination with HRT and to explore a new treatment model for R/R DLBCL patients with high tumor burden at baseline.
- Being tested
- Glofitamab + Obinutuzumab
- Keywords
- DLBCL, Glofitamab, radiotherapy
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glofitamab + ObinutuzumabDrug
Obinutuzumab An initial 1000 mg dose of obinutuzumab will be administered as pretreatment 7 days prior to the first glofitamab step-up dose
Glofitamab:
Glofitamab was administered intravenously as step-up doses on day 8 (2.5 mg) and day 15 (10 mg) of cycle 1, followed by a dose of 30 mg on day 1 of cycles 2 through 8, maximum of 12 cycles (Q3W). The efficacy is evaluated after 2 cycles of glofitamab. Those with disease progression will be withdrawn from the study. The remaining patients continue with an additional two cycles of glofitamab (4 cycles in total) and then perform efficacy assessment. If the patients achieve a CR or PR, they will continue to complete the remaining treatment as planned. Patients are recommended to treat for 12 cycles (at least 8 cycles, depending on tumor regression in patients) or until disease progression or unacceptable toxicity, whichever occurs first
| Study group | Role | What they receive |
|---|---|---|
| Glofitamab | Experimental | Utilizing intensity-modulated radiation therapy (IMRT); the radiation field follows the principles of involved site radiation therapy (ISRT). Total RT dose is 30 Gy/6 fraction, once daily, starting 8 days before Obinutuzumab pretreatment.
An initial 1000 mg dose of Obinutuzumab will be administered as pretreatment 7 days prior to the first Glofitamab step-up dose Glofitamab is administered intravenously as step-up doses on day 8 (2.5 mg) and day 15 (10 mg) of cycle 1, followed by a dose of 30 mg on day 1 of cycles 2 through 8, maximum of 12 cycles (Q3W). The efficacy is evaluated after 2 cycles of Glofitamab. Those with disease progression will be withdrawn from the study. The remaining patients continue with an additional two cycles of Glofitamab (4 cycles in total) and then perform efficacy assessment. If the patients achieve a CR or PR, they will continue to complete the remaining treatment as planned. Receives: Drug: Glofitamab + Obinutuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
defined as the percentage of patients whose best overall response was a CR according to the 2014 Lugano Response Criteria (Cheson, et al. 2014); as determined by the investigator
Measured: From enrollment to the end of treatment at 8 cycles (each cycle is 21 days)
Secondary outcomes (4)
Best response rate
defined as the proportion of patients whose best overall response is a PR or CR using 2014 Lugano Response Criteria (Cheson, et al. 2014)
Measured: From enrollment to the end of treatment at 8 cycles (each cycle is 21 days)
DoCR
defined as the time from the initial occurrence of a documented CR until documented disease progression or death due to any cause, whichever occurs first,. This will be evaluated using investigator assessment based on the 2014 Lugano Classification (Cheson, et al. 2014).
Measured: from the initial occurrence of a documented CR until documented disease progression or death due to any cause, assessed up to 48 months
PFS
defined as the time from the first study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first. PFS will be assessed by the investigator, using the 2014 Lugano classification (Cheson et al. 2014
Measured: the time from the first study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 48 months
OS
defined as the time from the first study treatment to the date of death from any cause.
Measured: the time from the first study treatment to the date of death from any cause, assessed up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start1 Apr 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liling Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liling Zhang, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06867536
- Sponsor's protocol ID
- UHCT241108
- Acronym
- GLOHRT-01
- Status last verified
- May 2026
- First submitted
- 11 Feb 2025
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- 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 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Phase Ⅱ Study to Evaluate the Efficacy and Safety of Hypofractionation Radiotherapy in Combination With Glofitamab in Relapsed/Refractory Diffuse B-cell Lymphoma With Baseline High Tumor Burden
- ClinicalTrials.gov ID
- NCT06867536
- Acronym / sponsor ID
- GLOHRT-01 / UHCT241108
- Keywords
- DLBCL, Glofitamab, radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Liling ZhangUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 10 Mar 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.
Glofitamab has shown efficacy and safety in the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and has been approved for marketing in China. However, in patients with baseline high tumor burden, the complete response (CR) rate is relatively lower compared with patients without. There is still a need to improve the efficacy of glofitamab in patients with high tumor burden. Previous studies have shown that hypofractionation radiotherapy (HRT) may induce T cell immune responses and improve the tumor microenvironment . Evidence shows that radiotherapy (RT) improves chimeric antigen receptor T-cell (CAR-T) efficacy as a bridging therapy . Based on the experience of RT combined with CAR-T, bispecific antibodies, as another T-cell therapy, may also demonstrate synergistic effects when combined with HRT, especially in those patients with bulky disease. This study will enroll R/R DLBCL patients with high tumor burden to assess the efficacy and safety of glofitamab in combination with HRT and to explore a new treatment model for R/R DLBCL patients with high tumor burden at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glofitamab | Experimental | Drug: Glofitamab + ObinutuzumabUtilizing intensity-modulated radiation therapy (IMRT); the radiation field follows the principles of involved site radiation therapy (ISRT). Total RT dose is 30 Gy/6 fraction, once daily, starting 8 days before Obinutuzumab pretreatment. An initial 1000 mg dose of Obinutuzumab will be administered as pretreatment 7 days prior to the first Glofitamab step-up dose Glofitamab is administered intravenously as step-up doses on day 8 (2.5 mg) and day 15 (10 mg) of cycle 1, followed by a dose of 30 mg on day 1 of cycles 2 through 8, maximum of 12 cycles (Q3W). The efficacy is evaluated after 2 cycles of Glofitamab. Those with disease progression will be withdrawn from the study. The remaining patients continue with an additional two cycles of Glofitamab (4 cycles in total) and then perform efficacy assessment. If the patients achieve a CR or PR, they will continue to complete the remaining treatment as planned. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent.
- Aged 18-75 years at the time of signing the informed consent, willing to follow and able to complete all study procedures.
- Expected survival ≥ 12 weeks.
- ECOG performance status score of 0-2 points ;
- Patients with CD20-positive DLBCL confirmed by pathological histology; (unspecified DLBCL, HGBCL, PMBCL, FL-transformed DLBCL).
Key exclusion criteria (19 listed)
- Individuals who have drug allergies or metabolic disorders to the drugs in this protocol.
- Previous recipients of allogeneic organ transplants.
- Individuals who received systemic immunotherapy within 4 weeks or 5 half-lives (whichever is shorter) of the drug.
- Anti-cancer drug treatment within 28 days before the start of treatment
- Prior radiotherapy in the mediastinum/pericardium area; radiation therapy for non-target lesion sites is allowed.
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 + ObinutuzumabObinutuzumab An initial 1000 mg dose of obinutuzumab will be administered as pretreatment 7 days prior to the first glofitamab step-up dose Glofitamab: Glofitamab was administered intravenously as step-up doses on day 8 (2.5 mg) and day 15 (10 mg) of cycle 1, followed by a dose of 30 mg on day 1 of cycles 2 through 8, maximum of 12 cycles (Q3W). The efficacy is evaluated after 2 cycles of glofitamab. Those with disease progression will be withdrawn from the study. The remaining patients continue with an additional two cycles of glofitamab (4 cycles in total) and then perform efficacy assessment. If the patients achieve a CR or PR, they will continue to complete the remaining treatment as planned. Patients are recommended to treat for 12 cycles (at least 8 cycles, depending on tumor regression in patients) or until disease progression or unacceptable toxicity, whichever occurs first | Drug | Glofitamab |
Primary outcome
Complete remission rate
Time frame: From enrollment to the end of treatment at 8 cycles (each cycle is 21 days)
defined as the percentage of patients whose best overall response was a CR according to the 2014 Lugano Response Criteria (Cheson, et al. 2014); as determined by the investigator
4 secondary outcomes
Best response rate
Time frame: From enrollment to the end of treatment at 8 cycles (each cycle is 21 days)
DoCR
Time frame: from the initial occurrence of a documented CR until documented disease progression or death due to any cause, assessed up to 48 months
PFS
Time frame: the time from the first study treatment to the first occurrence of disease progression or death from any cause, whichever occurs first, assessed up to 48 months
OS
Time frame: the time from the first study treatment to the date of death from any cause, assessed up to 48 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 15 May 2026.
- 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 2 study testing Glofitamab + Obinutuzumab in people with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) and Lymphoma, run by Liling Zhang 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 9 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 15 May 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?
Contact Liling Zhang (0086 27 83262660, lily1228@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete remission rate (time frame: From enrollment to the end of treatment at 8 cycles (each cycle is 21 days)). 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 15 May 2026.