eligibility_summary
Eligibility: Age 3-70 with CD19+ relapsed/refractory B-ALL (incl Ph+ after >=2 TKIs, or TKI-intolerant/contraindicated, or TKI-resistant mutations), marrow blasts >=5%, adequate organ function, LVEF >=50%, SpO2 >=92%, ECOG 0-2, life expectancy >3 mo, contraception required. Exclude: marrow failure syndromes, product allergy, active CNSL, isolated extramedullary disease, recent HSCT/active GVHD, major cardiac disease, uncontrolled infection, other active cancers, autoimmune/immunodeficiency, live vaccines <=4 wk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06307600 tests RD06-03, an autologous CD19-directed CAR-T cell therapy (cellular gene-modified immunotherapy) in relapsed/refractory B-ALL, including Ph+ ALL after TKI failure. Mechanism: patient T cells are engineered to express a chimeric antigen receptor recognizing CD19, CAR signaling (CD3ζ with costimulatory domain) activates T-cell effector functions to kill CD19+ cells via perforin/granzyme-mediated cytotoxicity and cytokine release, inducing apoptosis and B-cell aplasia. Target cells/pathways: CD19-expressing B-lymphoblasts, on-target effects on normal B cells, activation of T-cell cytotoxic and inflammatory pathways. Single IV infusion with dose-escalation (1×10^5, 3×10^5, 5×10^5 CAR+ T cells/kg). Primary aim: safety (DLTs), secondary: efficacy.