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

NCT07198373 | Not Yet Recruiting

• 1 other identifier: GBYY2527
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

B Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) rate at 24 months post-administration

  From date ofrandomization untilhe date of first documented progression , assessed up to 24 months

Secondary Outcomes (2)

• Progression-Free Survival (PFS)

  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)

  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 Arms (1)

Maintenance Therapy Group

Drug: Maintenance Therapy Group

Interventions

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.

Maintenance Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who achieve remission (complete or partial) at the 3-month post-CAR-T infusion assessment

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead

MeSH Terms

Conditions

Lymphoma, B-Cell

Condition Hierarchy (Ancestors)

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

Central Study Contacts

kai Hu

CONTACT

15810245863; hk13610956245@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Lymphoma Department at Beijing Gao Bo Hospital

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 30, 2025
• Study Start: September 20, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share