eligibility_summary
Inclusion: consent, age 18–65, R/R ALL (incl. post-HSCT relapse, Ph+ failing ≥2 TKIs), ≥5% marrow blasts, CD19+, ECOG 0–1, adequate organs (LVEF≥50%, Cr≤1.5×ULN or CrCl≥60, AST/ALT≤3×ULN, Tbili≤2×ULN), SpO2>91%, apheresis access, contraception, survival >3 mo. Exclusion: isolated extramedullary relapse (except CNS), active infection or HBV/HCV/HIV/syphilis/EBV/CMV DNA+, prior anti-CD19, recent steroids/DLI/radiation/anti‑T‑cell Abs/live vaccine, major cardiac/QTc≥480/HTN, organ/CNS/autoimmune/GVHD, pregnancy, other cancer <5 y, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm trial testing ssCART-19 plus lymphodepletion. Interventions/mechanisms: ssCART-19 (biological, CD19-directed chimeric antigen receptor T-cell therapy) given IV in split doses with 3+3 escalation, engineered autologous T cells recognize CD19 and, via CAR signaling, activate cytotoxicity to kill malignant B cells. Fludarabine (drug, purine analog antimetabolite) and cyclophosphamide (drug, alkylating agent) are used for lymphodepletion to enhance CAR-T expansion/persistence by reducing host lymphocytes. Targets: CD19 antigen on B-lineage blasts in relapsed/refractory ALL (including CNS disease), engages T-cell activation pathways and induces apoptosis of CD19+ cells, resulting in B-cell depletion.