eligibility_summary
Adults ≥18 with relapsed/refractory CD19+ B‑cell NHL (≥2 prior lines) needing systemic therapy, ECOG 0–1, life ≥10 wks, Part 2: measurable disease and biopsy consent, contraception required. Exclude: pregnancy, CD19‑negative, CNS lymphoma, recent malignancy, cytopenias, liver/renal/coag issues, major cardiac/pulmonary/hepatic/ocular/CNS disease, active infection (HIV/HBV/HCV), autoimmune on immunosuppression, unresolved ≥G2 AEs, recent surgery. Washouts: recent CD19 therapy/CAR‑T, other anticancer/investigational/radiation, transplant, live vaccines, steroids, nephrotoxins, strong CYP inhibitors, growth factors, herbs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05365659 tests IKS03 in advanced B‑cell NHL. Drug/intervention: IKS03, a CD19‑targeting antibody‑drug conjugate (human monoclonal IgG) linked to a pyrrolobenzodiazepine (PBD) pro‑drug, administered IV on Day 1 of 21‑day cycles (dose escalation then expansion). Mechanism of action: the anti‑CD19 antibody binds CD19 on B cells, is internalized, and releases/activates the PBD payload that binds the DNA minor groove to form interstrand crosslinks, blocking DNA replication/transcription and inducing apoptosis. Cells/pathways targeted: CD19‑positive malignant B lymphocytes (DLBCL, follicular lymphoma, mantle cell lymphoma, other B‑NHL), leverages CD19/B‑cell surface antigen for selective delivery and triggers tumor cell DNA damage/repair pathways leading to cell death.