OncoMatch/Clinical Trials/NCT06902012
Safety and Efficacy of Early Second Infusion of Axi-cel Based on ctDNA for R/R Large B - Cell Lymphoma
Is NCT06902012 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Infusion of Axicabtagene Ciloleucel for relapsed/refractory diffuse large b-cell lymphoma.
Treatment: Infusion of Axicabtagene Ciloleucel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: CAR-T cell therapy (axi-cel) — within 60 days prior
Within 60 days post-axi-cel: Persistent ctDNA(+) or ctDNA(-→+) under CR or PET/CT-confirmed PR
Cannot have received:
Grade ≥3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) following prior axi-cel therapy
Lab requirements
Blood counts
hemoglobin ≥80 g/l, absolute neutrophil count ≥1.0 ×10⁹/l, platelet count ≥75 ×10⁹/l, or parameters not meeting above thresholds but deemed acceptable for mononuclear cell collection per investigator's judgment
Kidney function
serum creatinine ≤2×uln or creatinine clearance ≥40 ml/min (cockcroft-gault formula)
Liver function
total bilirubin ≤2×uln (≤5×uln in gilbert syndrome), alt/ast ≤3×uln (≤5×uln in patients with hepatic involvement)
Cardiac function
left ventricular ejection fraction (lvef) >50%, baseline oxygen saturation >92% on room air
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify