eligibility_summary
Eligible: adults 18–80 with R/R NHL (DLBCL, PMBCL, HGBCL, FL3B, dose escalation also FL, MZL, MCL) or CLL/SLL after ≥2 regimens or post‑auto SCT, ECOG 0–1, measurable NHL (Lugano) or CLL meeting iwCLL, life expectancy ≥12 wks. Exclude: prior anti‑CD19 therapy (dose‑expansion requires prior approved CD19 CAR‑T), CNS disease, recent therapy/RT (<14 d, biologics <28 d), HSCT (auto <6 wks or any allo), active autoimmune/immunosuppression, major cardiac/CNS disorders.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: SC291, a hypoimmune allogeneic CD19-directed CAR T-cell therapy (genetically engineered T-cell immunotherapy), given after lymphodepleting chemotherapy with fludarabine (purine analog antimetabolite causing lymphocyte depletion) and cyclophosphamide (alkylating agent). Mechanisms: SC291 CAR binds CD19 on B cells to trigger T-cell activation and tumor cell killing, the hypoimmune design aims to evade host immune recognition and reduce alloreactivity for off-the-shelf use. Cells/pathways targeted: CD19+ malignant B cells (e.g., LBCL/DLBCL, PMBCL, HGBL, FL, MZL, MCL, CLL/SLL). Lymphodepletion targets host lymphocytes to enhance CAR T engraftment and expansion. Status: Phase 1, single-arm.