NCT07059741

Integrated Radiotherapy-optimized ASCT Sequential CAR-T Therapy for Patients With Relapsed and Refractory B-NHL

A Prospective Study of Integrated Radiotherapy-optimized ASCT Sequential CAR-T Therapy on the Efficacy and Safety of Patients With Relapsed and Refractory Aggressive B-cell Non-Hodgkin Lymphoma.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate a novel therapeutic strategy of integrated radiotherapy before autologous stem cell transplantation (ASCT) sequential chimeric antigen receptor T-cell(CAR-T) therapy for patients with relapsed/refractory(R/R) aggressive B-cell non-Hodgkin lymphoma (B-NHL). By evaluating the efficacy and safety of this multimodal approach, we seek to provide a theoretical foundation and clinical data to optimize outcomes for relapsed/refractory aggressive B-NHL patients.

Detailed description

This trial will enroll R/R aggressive B-NHL patients aged ≥18 years who have undergone at least two prior lines of systemic therapy. Participants will be stratified into two cohorts based on post-salvage therapy disease status: Cohort 1 (PET/CT-, ctDNA+): Patients will receive low-dose radiotherapy (RT) combined with reduced-intensity SEAM/TB chemotherapy as a conditioning regimen, followed by ASCT and sequential CAR-T therapy. Cohort 2 (PET/CT+, ctDNA+): Patients will receive high-dose RT combined with reduced-intensity SEAM/TB chemotherapy as a conditioning regimen, followed by ASCT and sequential CAR-T therapy. All patients completing the combined ASCT-CAR-T protocol will undergo longitudinal follow-up for safety, efficacy survival outcomes .

Conditions

• Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL)

Interventions

Type	Name	Description
OTHER	integrated low-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T	1. RT regimen: localized low dose RT: 1-1.5Gy/fraction\*5fractions 2. Reduced dose SEAM regimen (CNS uninvolved): * Simustine 250mg/m2 d-6 orally * Cytarabine 200mg/m2 q12h d-5\~d-4 intravenous infusion * Etoposide 100mg/m2 q12h d-5\~d-4 intravenous infusion * Melphalan 140mg/m2 q12h d-3 intravenous infusion 3. TB regimen (CNS involvement): * Thiotepa 250mg/m2 qd, d-8\~d-6 intravenous infusion * Busulfan 0.8mg/kg q6h d-5\~d-3 intravenous infusion
OTHER	integrated high-dose RT with reduced SEAM/TB conditioning before ASCT sequential CAR-T	1. RT regimen: localized high dose RT: 3-6Gy/fraction\*5fractions 2. Reduced dose SEAM regimen (CNS uninvolved): * Simustine 250mg/m2 d-6 orally * Cytarabine 200mg/m2 q12h d-5\~d-4 intravenous infusion * Etoposide 100mg/m2 q12h d-5\~d-4 intravenous infusion * Melphalan 140mg/m2 q12h d-3 intravenous infusion 3. TB regimen (CNS involvement): * Thiotepa 250mg/m2 qd, d-8\~d-6 intravenous infusion * Busulfan 0.8mg/kg q6h d-5\~d-3 intravenous infusion

Timeline

• Start date: 2024-12-10
• Primary completion: 2028-12-10
• Completion: 2028-12-10
• First posted: 2025-07-11
• Last updated: 2025-07-11

Locations

1 site across 1 country: China