eligibility_summary
Adults ≥18 with R/R aggressive B‑cell NHL (LBCL: DLBCL, HGBL double‑hit/NOS, PMBCL, FL3B, transformed indolent) after anthracycline+CD20, PET+, ECOG ≤2, adequate organs/vascular access, ineligible for HDCT/ASCT, survival >12 wks, contraception required. Exclude: primary CNS lymphoma, prior ≥2L therapy, active HBV/HCV/HIV/syphilis or uncontrolled infection, DVT/PE, uncontrolled DM/HTN, GVHD, autoimmune on IS, CV/CNS dz, pregnant/nursing, prior HSCT/CAR‑T, live vaccine <6 wks, severe allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Single-arm Phase 2 evaluating relmacabtagene autoleucel (JWCAR029) as second-line therapy for aggressive B‑cell NHL in transplant-ineligible adults. Interventions and mechanisms: • Relmacabtagene autoleucel – Biological (autologous CAR T-cell therapy). Patient T cells are engineered to express a chimeric antigen receptor targeting CD19 on B cells. Binding activates CAR signaling (via CD3ζ and costimulation), driving T‑cell proliferation, cytokine release, and cytotoxic killing of CD19+ malignant B cells. • Fludarabine – Drug (purine analog antimetabolite) used for lymphodepletion to reduce host lymphocytes and support CAR T expansion/engraftment. • Cyclophosphamide – Drug (alkylating agent) used for lymphodepletion with similar goals. Cells/pathways targeted: CD19-expressing B cells (DLBCL, HGBL, PMBCL, FL3B), T‑cell effector pathways triggered by CAR engagement of CD19.