RecruitingPhase 2NCT07538635

CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.

A Single-arm, Single-center, Open-label Clinical Study on the Efficacy and Safety of CAR-T Combined With ASCT in the Treatment of Relapsed/Refractory Large B-cell Lymphoma With High-risk Factors.


Sponsor

Zhejiang Cancer Hospital

Enrollment

20 participants

Start Date

Apr 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, single-center, open-label clinical study, aiming to evaluate the efficacy and safety of CAR-T combined with ASCT in the treatment of relapsed/refractory large B-cell lymphoma with high-risk factors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Axicabtagene Ciloleucel for people with high-risk r/r lbcl. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

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

BIOLOGICALAxicabtagene Ciloleucel

R/R LBCL with high-risk factors sequentially undergo leukapheresis, stem cell collection, bridging therapy (if applicable, at the investigator's discretion, with only one course of bridging therapy allowed), preconditioning chemotherapy phase (for CNSL patients: TB regimen, carmustine 300 mg/m² on Day -6, thiotepa 10 mg/kg on Day -5 to Day -4; for non-CNSL patients: BEAM regimen, carmustine 300 mg/m² on Day -7, etoposide 150 mg/m² on Day -6 to Day -3, cytarabine 200 mg/m² on Day -6 to Day -3, melphalan 140 mg/m² on Day -2; for patients with prior autologous hematopoietic stem cell transplantation, the investigator may develop other preconditioning regimens based on factors such as the patient's drug sensitivity and tolerability), stem cell infusion (Day 0), and CAR-T cell infusion (Day 4 to Day 7). A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10\^6 anti-CD19 CAR T cells/kg.


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhengjiang, China

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NCT07538635