eligibility_summary
≥55 with CD19+ ALL in 1st CR (any MRD), ECOG 0–1/KPS≥70, English for surveys, consent + archival tissue, no imminent transplant, recovered ≤G1 toxicities, adequate organ function (CrCl ≥60, LVEF ≥50%, O2>92%), negative/undetectable HIV/HBV/HCV, negative pregnancy, contraception. Exclude: refractory CNS disease, autoimmune/GVHD on immunosuppression, NYHA III/IV, active infection/recent cancer, systemic steroids, pregnant/breastfeeding, severe allergy, poor compliance.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05707273 (Phase I). Intervention: Autologous anti‑CD19 CAR T cells (gene‑modified, autologous T‑cell therapy) given as consolidation in first remission for older adults with CD19+ B‑ALL. Lymphodepleting chemo: fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent). Key procedures: leukapheresis, bone marrow and blood sampling. Mechanisms: Patient T cells are engineered to express a CAR that recognizes CD19, triggering antigen‑directed cytotoxicity and expansion upon engagement, fludarabine/cyclophosphamide decrease host lymphocytes to promote CAR T engraftment and activity. Targets: CD19 on malignant and normal B cells (leading to B‑cell aplasia), disease compartments include peripheral blood, bone marrow, and CSF, cytokine responses monitored.