eligibility_summary
Inclusion: Consent, R/R CD20+ DLBCL, MCL, or indolent lymphoma after ≥2 lines with no curative option (CD19 CAR ineligible, CD19−, or relapse post–CAR), Phase I ≥18y, Phase II all ages, measurable (Lugano), ECOG 0–2, adequate marrow (ANC≥1, Plt≥50) and organ function (CrCl≥30, ALT/AST≤2.5×ULN, bili<1.5×ULN, EF≥40), venous access, contraception. Exclusion: Burkitt/CNS/plasmablastic/Richter, major illness, HIV, organ compromise, rapid PD, active severe infection (e.g., HBV/HCV/TB), recent IP, tocilizumab allergy, recent steroids, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06002659 tests CAR20(NAP)-T (ELC-301), an autologous gene-modified CAR-T cell therapy for relapsed/refractory CD20+ B‑cell lymphomas. Drug/interventions: 1) CAR20(NAP)-T: T cells engineered with an anti‑CD20 CAR, upon CD20 engagement they express/secrete Helicobacter pylori Neutrophil‑Activating Protein (HP‑NAP), an immune‑stimulating factor. 2) Lymphodepleting chemotherapy: cyclophosphamide (alkylating agent) and fludarabine (purine analog). Mechanisms: anti‑CD20 CAR drives direct cytotoxicity of malignant B cells, secreted HP‑NAP activates innate immunity in the tumor microenvironment to induce bystander anti‑tumor responses and reduce antigen escape. Lymphodepletion enhances CAR‑T expansion/persistence. Targets: CD20 on B cells, tumor‑infiltrating innate immune cells (neutrophils/monocytes/dendritic cells), with downstream Th1/NK activation.