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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06902012 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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