eligibility_summary
Inclusion: 12–65, ECOG 0–1, life expectancy ≥12 wks, R/R B‑ALL (marrow blasts >5%), CD19+, adequate organ function, SpO2>92%, Ph+ ALL must have failed ≥2 TKIs or be intolerant/contraindicated, contraception and negative pregnancy test. Exclusion: extramedullary-only, Burkitt, CNS disease, prior HSCT/CAR‑T/CD19 therapy, active infection or HBV/HCV/HIV/CMV/EBV/syphilis, major CVD, drug allergy, recent therapy/radiation/steroids/surgery/vaccines, TB, thyroid/ILD, other recent cancers, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests Senl_B19 (S1904) autologous CD19 CAR‑T cells and the strategy of bridging allogeneic HSCT after CAR‑T–induced remission. Drug/type: S1904 is a gene‑modified, autologous T‑cell therapy expressing a chimeric antigen receptor targeting CD19. Mechanism: CAR engagement of CD19 on B cells activates T cells independent of native TCR, driving expansion, cytokine release, and cytotoxic killing (perforin/granzyme), leading to clearance of CD19+ leukemic blasts and B‑cell aplasia. Comparator/strategy: Randomization to undergo or not undergo allo‑HSCT after achieving MRD‑negative MLFS post‑CAR‑T. Allo‑HSCT mechanism: replaces hematopoiesis and provides graft‑versus‑leukemia immune effects that may reduce relapse. Cells/pathways targeted: CD19+ B‑lineage ALL cells, normal B cells, effector T‑cell cytotoxic pathways, in HSCT, donor T/NK alloreactivity (graft‑versus‑leukemia).