eligibility_summary
Adults ≥18 with follicular lymphoma grade 1–3A, relapsed/refractory after ≥2 prior lines including anti‑CD20 and an alkylator, PET‑avid (Deauville 4–5) and CT‑measurable disease, ECOG 0–2, adequate organ function, eligible for leukapheresis and selected standard care. Exclude grade 3B/transformed FL, prior anti‑CD19/gene/adoptive T‑cell therapy, CNS disease, significant infection (HIV/HBV/HCV), neuro‑autoimmune disorders, recent investigational drug, major cardiac disease. Other criteria may apply.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III randomized trial in adults with r/r follicular lymphoma comparing: 1) Tisagenlecleucel (CTL019), an autologous anti‑CD19 CAR‑T cell therapy, given after lymphodepleting chemo (fludarabine/cyclophosphamide or bendamustine) with optional bridging steroids/radiation. Mechanism: engineered T cells target CD19 on malignant B cells and kill via cytotoxicity, lymphodepletion enhances CAR‑T expansion. 2) Standard of care: R2 (lenalidomide, an IMiD that binds cereblon to degrade Ikaros/Aiolos and boost T/NK function, plus rituximab, an anti‑CD20 mAb mediating B‑cell depletion via ADCC/CDC) or R‑CHOP (rituximab + cyclophosphamide DNA crosslinking, doxorubicin topo II inhibition, vincristine microtubule blockade, prednisone lympholysis). Targets/pathways: CD19+ and CD20+ B cells, cereblon E3 ligase, T/NK cell activation, DNA replication/repair and mitosis, glucocorticoid receptor.