Actively Recruiting
Safety and Efficacy of Early Second Infusion of Axi-cel Based on ctDNA for R/R Large B - Cell Lymphoma
Led by Zhujiang Hospital · Updated on 2025-03-30
15
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Efficacy of Early Second Infusion of Axi-cel Based on ctDNA for R/R Large B - Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Life expectancy greater than 12 weeks
- ECOG performance status between 0 and 2
- Confirmed diagnosis of B-cell non-Hodgkin lymphoma including DLBCL, PMBCL, TFL, or HGBCL
- Relapsed or refractory disease defined by prior relapse, failure to achieve partial or complete response after standard therapies, or disease progression
- Adequate venous access for leukapheresis with sufficient blood counts or acceptable parameters as judged by investigator
- At least one measurable lesion according to Lugano 2014 criteria
- Renal function with serum creatinine ≤2 times upper limit or creatinine clearance ≥40 mL/min
- Cardiopulmonary function with left ventricular ejection fraction over 50% and oxygen saturation over 92% on room air
- Hepatic function with total bilirubin ≤2 times upper limit (≤5 times in Gilbert syndrome) and ALT/AST ≤3 times upper limit (≤5 times if hepatic involvement)
- Negative pregnancy test for women of childbearing potential; postmenopausal or surgically sterilized women exempt
- Persistent positive ctDNA or positive ctDNA conversion with CR or PET/CT confirmed partial response within 60 days after axi-cel infusion
You will not qualify if you...
- History of other malignancies within 5 years except adequately treated carcinoma in situ of cervix, basal or squamous cell skin cancer, localized prostate cancer after resection, breast ductal carcinoma in situ after surgery, or thyroid cancer after treatment
- Unstable systemic diseases including active infections (except localized), unstable angina, recent stroke or transient ischemic attack, recent myocardial infarction, severe heart failure (NYHA Class ≥III), severe arrhythmia needing medication, or severe hepatic, renal, or metabolic disorders
- Physical or psychological conditions impairing ability to consent or comply with the study
- Grade 3 or higher cytokine release syndrome or neurotoxicity after prior axi-cel therapy
- Active uncontrolled serious infections
- Uncontrolled active comorbid conditions that prevent study participation
- Other conditions deemed by investigator to pose unacceptable risk or make patient ineligible
AI-Screening
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Trial Site Locations
Total: 1 location
1
Zhujiang Hospital
Guangzhou, Guangdong, China, 510282
Actively Recruiting
Research Team
S
Sanfang Tu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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