RecruitingNot ApplicableNCT07059741

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.

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

20 participants

Start Date

Dec 10, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment sequence combining radiation therapy, stem cell transplantation (ASCT), and CAR-T cell therapy (a personalized immune cell treatment) for people with aggressive B-cell lymphoma that has relapsed (come back) or is refractory (no longer responding to treatment). **You may be eligible if...** - You are 18 years of age or older - You have been diagnosed with aggressive B-cell non-Hodgkin lymphoma confirmed by biopsy - Your lymphoma has relapsed or is refractory to prior treatment - Your life expectancy is more than 3 months - Your heart, liver, and kidney function meet required thresholds **You may NOT be eligible if...** - You have central nervous system involvement by lymphoma - You have active autoimmune disease - You have serious heart problems (ejection fraction below 50%) - You have significant liver or kidney dysfunction - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERintegrated 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

OTHERintegrated 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

Locations(1)

the First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT07059741