NCT06695013

Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk R/R B-NHL

Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk Relapsed/Refractory B Cell Non-Hodgkin Lymphoma(R/R B-NHL): A Multicenter, Prospective, Randomized, Open-label, Controlled Clinical Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore whether adding immunotherapy bridging treatment for low-risk refractory/relapsed B-NHL can demonstrate better outcomes, in order to find the most effective treatment plan for low-risk patients.

Detailed description

In the immunotherapy bridging treatment group, zanubrutinib ± radiotherapy will be used as the bridging treatment regimen, while those without bridging treatment will not receive bridging medications. Both groups will determine subsequent maintenance treatment based on efficacy at D28. Patients achieving complete response (CR) will not receive maintenance therapy, while those with partial response (PR) will be given oral zanubrutinib + PD-1 inhibitor for 2 years. Patients with stable disease (SD) or disease progression (PD) will not be included in this study.

Conditions

• B-NHL
• CART Therapy

Interventions

Type	Name	Description
DRUG	zanubrutinib	zanubrutinib 160 mg BID orally
DRUG	CAR-T	CAR-T Cell therapy
RADIATION	Bridging radiotherapy	For patients in the experimental group, the decision regarding radiotherapy will depend on whether the specific lesions are suitable.
DRUG	Tislelizumab	200mg IV Q3-4W

Timeline

• Start date: 2024-11-20
• Primary completion: 2026-11-20
• Completion: 2027-03-20
• First posted: 2024-11-19
• Last updated: 2025-01-24

Locations

1 site across 1 country: China