eligibility_summary
Eligibility: Age 3–65, R/R B-ALL with marrow blasts >5%, CSF leukemia, or measurable extramedullary disease, CD19 or CD22+, ECOG 0–2, survival ≥12 wks, adequate liver/renal function, contraception, negative pregnancy test. Exclude: CNS disease, autoimmune on immunosuppression, active infection, HBV/HCV/HIV/CMV/EBV/syphilis, cardiac disease, drug allergy, recent investigational/antitumor therapy, RT or surgery, systemic steroids, TB/other malignancy, vaccines, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Nanobody-based CD19/CD22 tandem dual CAR-T cells (autologous, gene‑modified cellular therapy). Mechanism: a single CAR with two nanobody (VHH) antigen‑binding domains simultaneously targets CD19 and CD22 on B‑lineage blasts, engagement activates CAR signaling (CD3ζ plus costimulatory domains), driving T‑cell activation, expansion, cytokine release, and perforin/granzyme‑mediated cytotoxic killing. Dual targeting aims to reduce antigen escape after prior CD19 or CD22 therapies. Preconditioning: fludarabine (purine antimetabolite) and cyclophosphamide (alkylator) lymphodepletion to improve CAR‑T engraftment/expansion. Cells/pathways targeted: malignant B cells in R/R B‑ALL expressing CD19 and/or CD22, key pathways include CAR‑T effector and cytokine/immune activation pathways (with CRS/ICANS risk monitored).