B Cell LymphomaNCT07198373
Exploratory Study on the Efficacy of Zebutinib as Maintenance Therapy Following CAR-T Cell Therapy in Patients With Non-Hodgkin B-Cell Lymphoma
An observational study of B Cell Lymphoma, run by Beijing GoBroad Hospital.
Trial summary
This study is a single-center, Phase IV clinical trial designed to collect and analyze data on the efficacy and safety of zanubrutinib as maintenance therapy following CAR-T cell therapy in subjects with non-Hodgkin B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B Cell Lymphoma
- What is being tested?
- Maintenance Therapy Group
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2025to 30 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 who achieve remission (complete or partial) at the 3-month post-CAR-T infusion assessment
Who may be able to join
- (1) Age ≥ 18 years, no gender restrictions; (2) Expected survival time exceeding 12 weeks; (3) Cytologically or histopathologically confirmed diagnosis of non-Hodgkin B-cell lymphoma according to WHO 2016 criteria; (4) Platelet count ≥ 50 × 10⁹/L; (5) Currently undergoing or scheduled to initiate oral zanubrutinib maintenance therapy following autologous or allogeneic CAR-T cell therapy; (6) Able to understand this trial and has signed an informed consent form.
Who cannot join
- (1) Pregnant or lactating individuals; male subjects planning to conceive within one year of treatment or within one year after cell reinfusion, or whose partners plan to conceive within one year after cell reinfusion; (2) Individuals with medical conditions that affect their ability to sign a written informed consent form or comply with study procedures; or those unwilling or unable to adhere to study requirements; (3) Individuals deemed unsuitable for participation in this trial by the investigator.
- Pregnant or lactating individuals; or male subjects planning to conceive within one year of treatment or within one year after cell infusion, or whose partners plan to conceive within one year after cell infusion; (2) Individuals with medical conditions that prevent signing a written informed consent form or complying with study procedures; or those unwilling or unable to comply with study requirements; (3) Individuals deemed unsuitable for this trial by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study is a single-center, Phase IV clinical trial designed to collect and analyze data on the efficacy and safety of zanubrutinib as maintenance therapy following CAR-T cell therapy in subjects with non-Hodgkin B-cell lymphoma.
- Conditions
- B Cell Lymphoma
- Being tested
- Maintenance Therapy Group
- 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.
Maintenance Therapy GroupDrug
Patients achieving remission (complete or partial) at the 3-month post-CAR-T infusion assessment receive oral zanubrutinib capsules for maintenance therapy for 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Maintenance Therapy Group | Not described Receives: Drug: Maintenance Therapy Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) rate at 24 months post-administration
Measured: From date ofrandomization untilhe date of first documented progression , assessed up to 24 months
Secondary outcomes (2)
Progression-Free Survival (PFS)
Measured: The time from the start of cell infusion to the first assessment of progression or death from any cause， assessed up to 5 years
Overall Survival (OS)
Measured: From date of randomization untilhe date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start20 Sep 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 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 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Hu, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198373
- Sponsor's protocol ID
- GBYY2527
- Status last verified
- Sep 2025
- First submitted
- 15 Sep 2025
- Last updated
- 30 Sep 2025
- 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 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on the Efficacy of Zebutinib as Maintenance Therapy Following CAR-T Cell Therapy in Patients With Non-Hodgkin B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07198373
- Acronym / sponsor ID
- GBYY2527
- Conditions
- B Cell Lymphoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Study start
- 20 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 30 Sep 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.
This study is a single-center, Phase IV clinical trial designed to collect and analyze data on the efficacy and safety of zanubrutinib as maintenance therapy following CAR-T cell therapy in subjects with non-Hodgkin B-cell lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Maintenance Therapy Group | – | Drug: Maintenance Therapy Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who achieve remission (complete or partial) at the 3-month post-CAR-T infusion assessment
Key inclusion criteria (1 listed)
- (1) Age ≥ 18 years, no gender restrictions; (2) Expected survival time exceeding 12 weeks; (3) Cytologically or histopathologically confirmed diagnosis of non-Hodgkin B-cell lymphoma according to WHO 2016 criteria; (4) Platelet count ≥ 50 × 10⁹/L; (5) Currently undergoing or scheduled to initiate oral zanubrutinib maintenance therapy following autologous or allogeneic CAR-T cell therapy; (6) Able to understand this trial and has signed an informed consent form.
Key exclusion criteria (2 listed)
- (1) Pregnant or lactating individuals; male subjects planning to conceive within one year of treatment or within one year after cell reinfusion, or whose partners plan to conceive within one year after cell reinfusion; (2) Individuals with medical conditions that affect their ability to sign a written informed consent form or comply with study procedures; or those unwilling or unable to adhere to study requirements; (3) Individuals deemed unsuitable for participation in this trial by the investigator.
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 |
|---|---|---|
| Maintenance Therapy GroupPatients achieving remission (complete or partial) at the 3-month post-CAR-T infusion assessment receive oral zanubrutinib capsules for maintenance therapy for 2 years. | Drug | Maintenance Therapy Group |
Primary outcome
Progression-free survival (PFS) rate at 24 months post-administration
Time frame: From date ofrandomization untilhe date of first documented progression , assessed up to 24 months
2 secondary outcomes
Progression-Free Survival (PFS)
Time frame: The time from the start of cell infusion to the first assessment of progression or death from any cause， assessed up to 5 years
Overall Survival (OS)
Time frame: From date of randomization untilhe date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 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 30 Sep 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.
Questions about this trial
What is this clinical trial studying?
An observational study of B Cell Lymphoma, run by Beijing GoBroad Hospital.
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 1 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 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 kai Hu (15810245863, hk13610956245@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) rate at 24 months post-administration (time frame: From date ofrandomization untilhe date of first documented progression , 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 30 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.