eligibility_summary
Eligibility: Age 18–65 with pathology‑confirmed relapsed/refractory large B‑cell NHL, measurable disease, ≥1 prior line, ECOG ≤2, adequate organ (LVEF ≥50%, CCr ≥30, ALT/AST ≤3×ULN) and marrow (platelets ≥45×10^9/L, Hgb ≥8 g/dL, ANC ≥1.0×10^9/L) function, survival ≥3 mo, contraception through 1 yr post‑study. Exclude recent/needed immunosuppression/steroids, uncontrolled infection, active HBV/HCV, HIV, prior CAR‑T/allo‑HSCT, other cancer, pregnancy/breastfeeding, serious comorbidity, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06381830 tests sequential autologous stem cell transplantation (ASCT) followed by CAR-T cell therapy in relapsed/refractory B‑cell Non‑Hodgkin’s lymphoma (Phase 2, single arm). Interventions: (1) Apheresis: G‑CSF–mobilized collection of CD34+ stem cells and separate PBMC collection for CAR‑T manufacturing. (2) ASCT: myeloablative conditioning then infusion of ≥2×10^6 CD34+ cells/kg to reconstitute hematopoiesis, debulk disease, and provide lymphodepletion. (3) CAR‑T cell therapy: autologous, genetically engineered T cells expressing a chimeric antigen receptor (adoptive cellular immunotherapy), infused 2–10×10^6/kg within 7 days post‑ASCT. Mechanisms: CARs use an antibody‑derived binding domain linked to T‑cell signaling/co‑stimulatory domains to recognize B‑cell tumor antigens independent of HLA, trigger T‑cell activation, cytotoxic killing, and cytokine release. Targets: malignant B cells in LBCL, B‑cell surface antigens (unspecified), pathways include T‑cell effector and cytokine signaling, hematopoietic stem cells for transplant.