eligibility_summary
Eligibility: Consent, life expectancy ≥3 mo, no severe cardiopulmonary disease, CD19+ r/r B-ALL (1–60 y) or B-NHL (18–65 y), autologous CAR-T failure (apheresis/T-cell yield ≤10%/expansion) or no benefit after auto CAR-T within 1 mo, ECOG 0–2, adequate counts/chemistry, LVEF ≥55%, negative HIV/TP/HBV/HCV, contraception. Exclude: pregnant/plans, prior GVHD tx, recent allo cells/HSCT, isolated extramedullary B-ALL, severe mental/autoimmune/CVD, coagulopathy, active infection, other malignancy, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD19-UCART (biological, allogeneic “off‑the‑shelf” CAR‑T cell therapy). Mechanism: Donor-derived T cells engineered with a chimeric antigen receptor recognizing CD19, CAR engagement activates cytotoxic T-cell pathways (perforin/granzyme, cytokine release) to eliminate CD19+ malignant B cells. Conditioning: cyclophosphamide (alkylating agent) + fludarabine (purine analog), ± etoposide/VP16 (topoisomerase II inhibitor) for lymphodepletion to enhance CAR‑T expansion/persistence. Cells/pathways targeted: CD19 on B-lineage cells (malignant B-ALL and B‑NHL, also normal B cells), with preconditioning targeting host lymphocytes. Study: single-arm Phase 1 in relapsed/refractory CD19+ B-cell malignancies.