Relapsed or Refractory B-Cell Non-Hodgkin LymphomaNCT07695896
Real-World Study of Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
An observational study of Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, run by Yanyan Liu at 1 site in China.
Trial summary
B-cell non-Hodgkin lymphoma (B-NHL) is the most common type of lymphoma. Although first-line R-CHOP can cure a proportion of patients, approximately 30%-40% relapse or become refractory (R/R). CD20xCD3 bispecific antibodies, represented by glofitamab, have shown significant efficacy in clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
- What is being tested?
- Glofitamab
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2026to Dec 2028
- Phase
- Observational
- 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
Study population: Patients with relapsed or refractory B-cell non-Hodgkin lymphoma who receive a CD20xCD3 bispecific antibody-containing regimen (e.g., glofitamab) in routine clinical practice at participating hospitals in China.
Who may be able to join
- Age >= 18 years at the start of treatment
- Histologically confirmed B-cell non-Hodgkin lymphoma
- Relapsed or refractory disease after at least one prior line of systemic therapy
- Planned to receive a CD20xCD3 bispecific antibody-containing regimen after study initiation
- Signed informed consent for the investigational treatment
Who cannot join
- Currently participating in, or planning to participate in, any interventional clinical trial
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this 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
Henan Cancer Hospital
Zhengzhou, Henan
Yanyan Liu, +86 13838176375, yyliu@zzu.edu.cn
About this study
Official title: A Real-World Study on the Efficacy and Safety of Bispecific Antibody in the Treatment of Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
B-cell non-Hodgkin lymphoma (B-NHL) is the most common type of lymphoma. Although first-line R-CHOP can cure a proportion of patients, approximately 30%-40% relapse or become refractory (R/R). CD20xCD3 bispecific antibodies, represented by glofitamab, have shown significant efficacy in clinical trials. However, large-scale real-world efficacy and safety data in Chinese clinical practice are still lacking, particularly regarding combination with different regimens and use in the relapsed population.
This is a prospective, multicenter, observational registry study evaluating the efficacy and safety of CD20xCD3 bispecific antibody-containing regimens in patients with relapsed or refractory B-cell non-Hodgkin lymphoma in a real-world setting. Efficacy is assessed using the Lugano 2014 response criteria. The primary endpoint is best objective response rate (ORR).
Read the detailed description
Study design: Prospective, multicenter, observational (non-interventional) registry study.
Population: Patients aged >=18 years with histologically confirmed B-cell non-Hodgkin lymphoma who are relapsed or refractory after at least one prior line of therapy and who receive a CD20xCD3 bispecific antibody-containing regimen after study initiation.
Efficacy evaluation: Lugano 2014 response criteria.
Primary endpoint: Best objective response rate (ORR).
Secondary endpoints: Complete response rate (CRR), disease control rate (DCR), duration of response (DOR), time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), and safety.
Exploratory endpoints: Subgroup analyses by combination pattern (e.g., combined with chemotherapy or targeted agents) and special populations; correlation of biomarkers (e.g., peripheral blood lymphocyte subsets, T-lymphocyte mitochondrial immune analysis, cytokines) with efficacy and safety; and patient compliance and quality-of-life analyses based on electronic patient-reported outcomes (ePRO).
Planned enrollment: 200 participants. As a non-interventional study, no formal statistical hypothesis is tested; the sample size is based on the confidence-interval width method (expected ORR P=0.5, half-width d=0.07), yielding approximately 196 participants, rounded to 200.
- Being tested
- Glofitamab
- Keywords
- B-cell non-Hodgkin lymphoma, Bispecific antibody, Glofitamab, CD20xCD3, Real-world study, Relapsed refractory
- Medical subject headings
- Recurrence, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlofitamabBiological
Glofitamab, a CD20xCD3 bispecific monoclonal antibody, administered per real-world clinical practice and product labeling. As an observational study, treatment is determined by the treating physician and not by the study protocol; the intervention of interest is recorded to describe the treated population.
| Study group | Role | What they receive |
|---|---|---|
| R/R B-NHL treated with bispecific antibody | Patients with relapsed or refractory B-cell non-Hodgkin lymphoma who receive a CD20xCD3 bispecific antibody-containing regimen (e.g., glofitamab) in routine clinical practice. This is a single observational cohort; no treatment is assigned by the study. Receives: Biological: Glofitamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Overall Response Rate (ORR)
ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to the Lugano 2014 response criteria for malignant lymphoma.
Measured: From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years
Secondary outcomes (7)
Disease Control Rate (DCR)
DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) per Lugano 2014 criteria.
Measured: From treatment initiation until disease progression, assessed up to approximately 2 years
Duration of Response (DOR)
DOR is defined as the time from the first documented CR or PR to the first documented disease progression or death from any cause, whichever occurs first, among responders.
Measured: From first response until disease progression or death, assessed up to approximately 2 years
Time to Next Treatment (TTNT)
TTNT is defined as the time from treatment initiation to the start of the next line of anti-lymphoma therapy or death from any cause, whichever occurs first.
Measured: From treatment initiation until start of next therapy or death, assessed up to approximately 2 years
Progression-Free Survival (PFS)
PFS is defined as the time from treatment initiation to the first documented disease progression per Lugano 2014 criteria or death from any cause, whichever occurs first.
Measured: From treatment initiation until disease progression or death, assessed up to approximately 2 years
Overall Survival (OS)
OS is defined as the time from treatment initiation to death from any cause.
Measured: From treatment initiation until death from any cause, assessed up to approximately 2 years
Incidence of Adverse Events (Safety)
Safety is assessed by the incidence, severity, and type of adverse events (AEs) and serious adverse events (SAEs), including adverse events of special interest such as cytokine release syndrome (CRS), graded per NCI CTCAE and, for CRS, per ASTCT consensus criteria.
Measured: From treatment initiation until 90 days after last dose, assessed up to approximately 2 years
Complete Response Rate (CRR)
CRR is defined as the proportion of participants achieving a best overall response of complete response (CR) per Lugano 2014 criteria.
Measured: From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study startJul 2026 (estimated)
- Primary completionDec 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 Relapsed or Refractory B-Cell Non-Hodgkin LymphomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanyan Liu
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Yanyan Liu, Henan Cancer Hospital
- Investigators
- Yanyan Liu, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695896
- Sponsor's protocol ID
- HNSZLYYNHL12
- Other IDs
- 2026-254
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Study on the Efficacy and Safety of Bispecific Antibody in the Treatment of Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT07695896
- Acronym / sponsor ID
- HNSZLYYNHL12
- Keywords
- B-cell non-Hodgkin lymphoma, Bispecific antibody, Glofitamab, CD20xCD3, Real-world study, Relapsed refractory
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yanyan LiuOther government
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Jul 2026 (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.
B-cell non-Hodgkin lymphoma (B-NHL) is the most common type of lymphoma. Although first-line R-CHOP can cure a proportion of patients, approximately 30%-40% relapse or become refractory (R/R). CD20xCD3 bispecific antibodies, represented by glofitamab, have shown significant efficacy in clinical trials. However, large-scale real-world efficacy and safety data in Chinese clinical practice are still lacking, particularly regarding combination with different regimens and use in the relapsed population.
This is a prospective, multicenter, observational registry study evaluating the efficacy and safety of CD20xCD3 bispecific antibody-containing regimens in patients with relapsed or refractory B-cell non-Hodgkin lymphoma in a real-world setting. Efficacy is assessed using the Lugano 2014 response criteria. The primary endpoint is best objective response rate (ORR).
Detailed description
Study design: Prospective, multicenter, observational (non-interventional) registry study.
Population: Patients aged >=18 years with histologically confirmed B-cell non-Hodgkin lymphoma who are relapsed or refractory after at least one prior line of therapy and who receive a CD20xCD3 bispecific antibody-containing regimen after study initiation.
Efficacy evaluation: Lugano 2014 response criteria.
Primary endpoint: Best objective response rate (ORR).
Secondary endpoints: Complete response rate (CRR), disease control rate (DCR), duration of response (DOR), time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), and safety.
Exploratory endpoints: Subgroup analyses by combination pattern (e.g., combined with chemotherapy or targeted agents) and special populations; correlation of biomarkers (e.g., peripheral blood lymphocyte subsets, T-lymphocyte mitochondrial immune analysis, cytokines) with efficacy and safety; and patient compliance and quality-of-life analyses based on electronic patient-reported outcomes (ePRO).
Planned enrollment: 200 participants. As a non-interventional study, no formal statistical hypothesis is tested; the sample size is based on the confidence-interval width method (expected ORR P=0.5, half-width d=0.07), yielding approximately 196 participants, rounded to 200.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R/R B-NHL treated with bispecific antibody | – | Biological: GlofitamabPatients with relapsed or refractory B-cell non-Hodgkin lymphoma who receive a CD20xCD3 bispecific antibody-containing regimen (e.g., glofitamab) in routine clinical practice. This is a single observational cohort; no treatment is assigned by the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with relapsed or refractory B-cell non-Hodgkin lymphoma who receive a CD20xCD3 bispecific antibody-containing regimen (e.g., glofitamab) in routine clinical practice at participating hospitals in China.
Key inclusion criteria (5 listed)
- Age >= 18 years at the start of treatment
- Histologically confirmed B-cell non-Hodgkin lymphoma
- Relapsed or refractory disease after at least one prior line of systemic therapy
- Planned to receive a CD20xCD3 bispecific antibody-containing regimen after study initiation
- Signed informed consent for the investigational treatment
Key exclusion criteria (2 listed)
- Currently participating in, or planning to participate in, any interventional clinical trial
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
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 |
|---|---|---|
| GlofitamabGlofitamab, a CD20xCD3 bispecific monoclonal antibody, administered per real-world clinical practice and product labeling. As an observational study, treatment is determined by the treating physician and not by the study protocol; the intervention of interest is recorded to describe the treated population. | Biological | R/R B-NHL treated with bispecific antibody |
Primary outcome
Best Overall Response Rate (ORR)
Time frame: From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years
ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to the Lugano 2014 response criteria for malignant lymphoma.
7 secondary outcomes
Disease Control Rate (DCR)
Time frame: From treatment initiation until disease progression, assessed up to approximately 2 years
Duration of Response (DOR)
Time frame: From first response until disease progression or death, assessed up to approximately 2 years
Time to Next Treatment (TTNT)
Time frame: From treatment initiation until start of next therapy or death, assessed up to approximately 2 years
Progression-Free Survival (PFS)
Time frame: From treatment initiation until disease progression or death, assessed up to approximately 2 years
Overall Survival (OS)
Time frame: From treatment initiation until death from any cause, assessed up to approximately 2 years
Incidence of Adverse Events (Safety)
Time frame: From treatment initiation until 90 days after last dose, assessed up to approximately 2 years
Complete Response Rate (CRR)
Time frame: From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years
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 10 Jul 2026.
Related trials for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
RecruitingPhase 1/2
Dose Escalation and Dose Expansion Study of MDX2003 in Patients With Different Types of Lymphoma
Lymphoma, Waldenström Macroglobulinemia (WM)
Active, not recruitingPhase 1
A Study of Radiation Therapy Before CAR T Cell Therapy for People With B Cell Lymphoma
Non-Hodgkin Lymphoma, Non-Hodgkin's Lymphoma, Relapsed
RecruitingObservational study
An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
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.
Yanyan Liu principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma, run by Yanyan Liu 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 5 inclusion and 2 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 10 Jul 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.
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 Yanyan Liu (+86 13838176375, yyliu@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Overall Response Rate (ORR) (time frame: From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years). 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 10 Jul 2026.