eligibility_summary
Eligible: ECOG 0–1, newly diagnosed B‑ALL within 6 months in CR1 after induction and ≥1 consolidation—Ph− with MRD ≥0.01% by flow, or Ph+ with detectable BCR‑ABL1 by qPCR, no significant organ dysfunction, willing/eligible for autologous HSCT. Exclude: Burkitt/double‑expressor, CML blast phase, ≥5% blasts or extramedullary disease, prior CAR‑T or HSCT, marrow failure syndromes (Fanconi, Kostmann, Shwachman, etc.).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm trial in MRD-positive B-cell ALL in first complete remission testing: 1) Inaticabtagene autoleucel (CNCT19), an autologous CD19-directed CAR-T cell therapy (genetically modified cellular immunotherapy), 2) Autologous hematopoietic stem cell transplantation (auto-HSCT). Mechanisms: CAR-T cells bind CD19 on B-lineage cells, triggering T-cell activation and cytotoxic killing to eradicate minimal residual disease, auto-HSCT allows high-dose conditioning and hematopoietic rescue to consolidate remission. Targets/pathways: CD19-positive leukemic B cells (normal B cells also depleted), CAR-mediated T-cell signaling, MRD in bone marrow.