eligibility_summary
Children <18 yrs, ≥6 kg, with r/r CD19+ B‑ALL (primary refractory, first relapse [high‑risk timing, DS/KMT2A infants any time, refractory MRD ≥0.01%], ≥second relapse, post‑allo‑SCT ≥3 mo, or Ph+ after/intolerant to TKI) or r/r aggressive mature B‑NHL (DLBCL, Burkitt, PMBCL, high‑grade NOS) relapsed ≥1 tx or primary refractory, measurable. PS ≥50, CD19+, adequate organs. Exclude CML‑LBC, CNS‑3/active CNS‑2/other CNS disease, active infection, SCT <3 mo, prior CD19 (except blina), ≥G3 blina neurotox.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06173518 tests AUTO1 (obecabtagene autoleucel, obe‑cel), an autologous anti‑CD19 chimeric antigen receptor (CAR) T‑cell therapy (cellular, gene‑modified immunotherapy) in pediatric r/r B‑ALL and aggressive mature B‑NHL. Mechanism: a patient’s T cells are engineered to express a CAR that binds CD19 on B cells, antigen engagement triggers CAR signaling and T‑cell cytotoxicity, eliminating CD19‑positive malignant B cells and inducing B‑cell aplasia. Patients receive lymphodepleting chemotherapy (fludarabine/cyclophosphamide) to promote CAR‑T expansion. Targets: CD19 on B‑lineage cells, T‑cell activation via CAR/CD3ζ pathways.