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

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)

Trial Details

NCT ID

NCT06902012

Phase

PHASE1 / PHASE2

Sponsor

Zhujiang Hospital

Status

RECRUITING

Cancer Type

Lymphoma

Interventions

• Infusion of Axicabtagene Ciloleucel

Locations (sample)

• Guangzhou, Guangdong, China|23.11667,113.25

Key Eligibility Criteria

• Age ≥18 years, regardless of gender.
• Life expectancy \>12 weeks.
• ECOG performance status 0-2.
• Histologically or cytologically confirmed B-cell non-Hodgkin lymphoma per WHO 2016 classification, including:

For full eligibility, visit ClinicalTrials.gov.

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