RecruitingPhase 1Phase 2NCT06902012

Safety and Efficacy of Early Second Infusion of Axi-cel Based on ctDNA for R/R Large B - Cell Lymphoma

A Prospective, Single - Arm Clinical Study on the Safety and Efficacy of Early Second Infusion of CD19 CAR - T Based on ctDNA Monitoring in the Treatment of Relapsed/Refractory Large B - Cell Lymphoma


Sponsor

Zhujiang Hospital

Enrollment

15 participants

Start Date

Feb 1, 2027

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of early secondary infusion of CD19 CAR T-cell therapy in adults with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), guided by ctDNA monitoring. The main questions it aims to answer are: 1. Efficacy: Does early secondary CAR-T infusion improve the 3-month complete remission (CR) rate and long-term survival outcomes (e.g., 1-year PFS, OS)? 2. Safety: What are the adverse events associated with secondary CAR-T infusion, such as cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity (ICANS), and infections? This is a single-arm, single-center, prospective study. All participants will receive: * Leukapheresis to collect T cells for CAR-T manufacturing. * Preconditioning chemotherapy (fludarabine and cyclophosphamide) to prepare the body for CAR-T infusion. * Two CD19 CAR-T infusions: The first infusion (2×10⁶ cells/kg) followed by a second infusion (same dose) if ctDNA remains positive when PET/CT shows CR or PET/CT shows PR within 60 days post-first infusion. Participants will undergo: * Frequent hospital monitoring for ≥14 days post-infusion to manage potential toxicities. * Regular follow-ups (e.g., blood tests, ctDNA analysis, PET/CT scans) at scheduled intervals up to 12 months. * Continuous safety assessments, including CRS grading, neurological evaluations, and infection monitoring.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether giving a second dose of axi-cel (a personalized CAR-T cell therapy) early — guided by a blood test called ctDNA — can improve outcomes for patients with relapsed or hard-to-treat large B-cell lymphoma (a type of blood cancer). **You may be eligible if...** - You are 18 or older with confirmed B-cell non-Hodgkin lymphoma (including DLBCL, PMBCL, transformed follicular lymphoma, or high-grade B-cell lymphoma) - Your cancer has relapsed or has not responded to prior treatment - You are in adequate physical health (ECOG 0-2) with a life expectancy of at least 12 weeks - You have adequate blood vessel access for the cell collection process **You may NOT be eligible if...** - You have active brain involvement by lymphoma - You have active autoimmune disease requiring treatment - You have had a prior stem cell transplant within the last 6 months - You have severe organ dysfunction or uncontrolled infections 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

DRUGInfusion of Axicabtagene Ciloleucel

Drug: Axicabtagene Ciloleucel (CD19 CAR-T cells), 2×106 cells/kg, IV infusion at Day 0 and 30-90 days post-first infusion. Drug: Cyclophosphamide (500 mg/m²) + Fludarabine (30 mg/m²), IV on Days -5, -4, -3. Procedure: ctDNA monitoring via liquid biopsy at pre-lymphodepletion and Months 1, 2, 3, 6, 9, 12 post-infusion.


Locations(1)

Zhujiang Hospital

Guangzhou, Guangdong, China

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NCT06902012


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