Exploratory Study on the Efficacy of Zebutinib as Maintenance Therapy Following CAR-T Cell Therapy in Patients With Non-Hodgkin B-Cell Lymphoma

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.

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Key information

Conditions

B Cell Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(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.

Exclusion criteria

(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.

Treatment and study plan

Maintenance Therapy Group

Drug

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.

Primary outcomes

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

kai Hu

CONTACT

[email protected]

15810245863

Sponsors and collaborators

Lead sponsor

Beijing GoBroad Hospital

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Sep 30, 2025
Registry last updated: Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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