eligibility_summary
Inclusion: Adults ≥18 with relapsed/refractory PTCL (WHO 2022, Part 1 subtypes) after ≥1 systemic therapy (ALCL: brentuximab or intolerant), measurable disease, ECOG 0-1, >3 mo life expectancy, adequate labs, tissue/marrow available, contraception. Exclusion: bulky ≥10 cm, CNS disease, excluded T/NK entities, other active cancers ≤3 y, recent therapy/transplant/cell tx/steroids, unresolved AEs, active HIV/HBV/HCV/TB, live vaccine <35 d, pregnancy, significant autoimmune/lung/heart/liver/bleeding disorders, uncontrolled HTN, noncompliance, hypersensitivity, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Intervention: LIS1, an IV glyco-humanized polyclonal (polyspecific) antibody. Mechanism: engineered human-like glycosylation and multi-epitope binding to malignant T‑cell surface antigens, aiming to eliminate tumor T cells via Fc-mediated immune effector functions (e.g., ADCC, CDC) and possible direct neutralization. Type: antibody-based immunotherapy (polyclonal). Targets: malignant peripheral T cells in PTCL subtypes (e.g., ALCL, nodal TFH, hepatosplenic, intestinal T‑cell lymphomas). Cells/pathways engaged: tumor T-cell surface antigens, Fc receptor–bearing effector cells (e.g., NK cells) and complement activation.