eligibility_summary
Eligible: adults with high‑risk B‑ALL in complete remission post‑induction, with autologous CD19 CAR‑T prepared, eligible for autologous hematopoietic stem cell transplant (HSCT), and no major organ dysfunction. Exclude: other malignancies, uncontrolled serious infection, positive for syphilis/HIV/HBV/HCV, allergy to study/similar drugs, or any condition investigators deem unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm trial in adult high‑risk B‑ALL tests a combined cellular therapy: autologous hematopoietic stem cell transplantation (auto‑HSCT) followed by autologous CD19 CAR T cells (e.g., inaticabtagene autoleucel) infused on day +7. Drug/intervention types: biological/cellular therapies. Mechanisms: Auto‑HSCT reinfuses patient CD34+ hematopoietic stem/progenitor cells after conditioning to restore marrow and reduce tumor burden. CD19 CAR T cells are genetically engineered autologous T lymphocytes that bind CD19 on B cells, activating via CAR (CD3ζ with costimulation) to mediate cytotoxic killing and cytokine release, inducing B‑cell aplasia and MRD eradication. Targets: CD19+ B‑ALL blasts/normal B cells, T‑cell effector pathways, hematopoietic reconstitution via HSC engraftment.