NCT07264894

ZSDT for the Treatment of R/R Mantle Cell Lymphoma After BTK Inhibitor Failure: a Multi-center Prospective Clinical Trial

ZSDT for the Treatment of Recurrent Refractory Mantle Cell Lymphoma After BTK Inhibitor Failure: a Multi-center Prospective Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

For relapsed/refractory mantle cell lymphoma patients that previously treated with BTK inhibitors: The first part involves 6 cycles of combined therapy with zuberitamab, selinexor, dexamethasone, and thalidomide. This targeted combination regimen can enhance efficacy while reducing toxic side effects. The second part utilizes Zuberitamab plus selinexor for maintenance consolidation therapy, thereby reducing relapse and prolonging survival.

Conditions

• Mantle Cell Lymphoma (MCL)

Interventions

Type	Name	Description
DRUG	ZSDT regimen	The study is based on the R2 protocol and preclinical and clinical studies of selinexor. For relapsed refractory MCL patients who had received BTK inhibitors: selinexor 60mg once daily on days 1 and 8, zuberitamab 375 mg/m² on day 0, Dexamethasone 20 mg on days 1-3 and 8-9, and thalidomide 200 mg on days 1-21. Each treatment cycle lasted 21 days, with six consecutive cycles. Patients achieving complete remission (CR) or partial response (PR) would receive a year-long maintenance therapy of zuberitamab 375 mg/m² every three months and selinexor 60 mg daily on days 1 and 8. Patients experiencing disease progression (PD) would be excluded from the study.

Timeline

• Start date: 2025-12-31
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study