eligibility_summary
Eligible: age 1–25 with CD19+ R/R B‑ALL, previously received tisagenlecleucel and a 2nd product available. Cohort 1: early B‑cell aplasia loss <6 mo in CR/MRD–, Cohort 2: loss of B‑cell aplasia with detectable CD19+ disease. Need life expectancy >12 wks, PS ≥70, no organ dysfunction, consent/insurance. Exclude: any leukemia therapy after 1st Kymriah, pneumonitis, autoimmune tx, prior PD‑1/PD‑L1, recent vax/chemo/mAbs, other CD19/CD3 (except blina/Kymriah), infections (HBV/HCV/HIV), GVHD, CNS‑3, pregnancy, hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I/II single-arm trial in pediatric/AYA CD19+ B-ALL tests: 1) Tisagenlecleucel (Kymriah), an autologous anti-CD19 CAR T-cell therapy that targets CD19 on B cells to kill leukemia, 2) Nivolumab (Opdivo), a monoclonal antibody immune checkpoint inhibitor that blocks PD-1 on T cells, preventing PD-1/PD-L1 signaling to reinvigorate/expand CAR T cells. Lymphodepletion with fludarabine/cyclophosphamide (cytotoxic chemotherapy) precedes CAR-T reinfusion, nivolumab is started at varying times (day −1 to day 14). Targets/pathways: CD19 on malignant B cells, PD-1/PD-L1 checkpoint on T cells/tumor microenvironment. Goal: overcome CAR T-cell non-persistence and restore B-cell aplasia.