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

NCT06902012 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-03-30

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory Diffuse Large B-cell Lymphoma

Interventions

DRUG

Infusion 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.

Sponsors & Collaborators

  • Zhujiang Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-02-28
Primary Completion
2028-02-29
Completion
2028-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06902012 on ClinicalTrials.gov