eligibility_summary
Adults 18–75, ECOG 0–2, life expectancy ≥3 months, relapsed/refractory CD19+ B‑ALL or B‑cell lymphoma per criteria, with measurable disease and adequate prior therapy (incl anti‑CD20/anthracycline for lymphoma). Adequate organ function and LVEF ≥50%, consent required. Exclude CNS disease, ≥G2 non‑heme toxicity, recent/serious cardiac/cerebrovascular disease, high‑dose steroids/immunosuppression, active IV‑treated infection, biologic allergy, non‑HCT transplant, pregnancy/lactation, no contraception, instability, substance abuse, or investigator concern.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Early Phase I, single-arm study of JD001, an allogeneic CD19-CAR-NK cell therapy, in relapsed/refractory B‑cell malignancies (ALL, B‑cell lymphoma, CLL). Intervention/mechanism: Gene‑modified natural killer cells engineered with a chimeric antigen receptor targeting CD19 (cellular immunotherapy). The CAR enables antigen‑specific recognition of CD19+ B cells and triggers NK‑cell cytotoxicity (perforin/granzyme release and cytokine‑mediated killing), promoting clearance of malignant B cells. Preconditioning: fludarabine (purine analog lymphodepletor), cyclophosphamide (alkylating agent), and etoposide (topoisomerase II inhibitor) to reduce host lymphocytes and support CAR‑NK expansion. Targets: CD19 on B cells, engages NK activation pathways, lymphodepletion targets proliferating lymphocytes. Doses: 1×10^6, 5×10^6, 2×10^7 cells/kg. Primary focus: safety, DLTs, MTD/RP2D.