eligibility_summary
Eligibility: Histologically confirmed B‑cell NHL (DLBCL, high‑grade ± MYC/BCL2/BCL6, transformed, PMBCL, FL), relapsed/refractory after anti‑CD20 + anthracycline per defined criteria, ≥1 high‑risk feature (extranodal, bulky ≥5 cm, TP53), ECOG 0–2, eligible for HDCT/ASCT then CAR‑T, adequate renal/hepatic, EF ≥40%, SpO2 >95%, life ≥3 mo. Exclude: prior SCT, active HBV/HCV, uncontrolled infection/major disease, HIV, prior anti‑CD19 CAR‑T, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: high-dose chemotherapy with autologous stem-cell transplantation (HDT/ASCT), followed by relmacabtagene autoleucel (relma-cel) on day +3. Relma-cel is an autologous, CD19-directed CAR-T cell therapy (gene-modified cellular immunotherapy). Mechanisms: HDT provides cytoreduction and lymphodepletion, ASCT rescues hematopoiesis and supports immune reconstitution. Relma-cel CAR-T cells are engineered to express a chimeric antigen receptor that binds CD19 on B cells, triggering CAR signaling (CD3ζ with costimulation), T-cell activation/expansion, cytokine release, and perforin/granzyme-mediated cytotoxic killing. Targets: CD19-expressing malignant B cells in B-NHL (with expected on-target B-cell aplasia), leverages the post-transplant lymphodepleted milieu to enhance CAR-T expansion and activity.