eligibility_summary
Include: Adults ≥18 w/ R/R CD19+ NHL/ALL/CLL(Richter) after ≥2 lines, ECOG ≤2, >12‑wk expectancy, adequate organs, contraception rules, toxicities ≤G2, product manufactured, infection‑free, washouts met. Exclude: recent SCT/CAR‑T, active TB/HBV/HCV/HIV, autoimmune needing immunosuppression, pregnancy/breastfeeding, recent major surgery, unstable brain mets, major cardiac issues, major CNS disease, severe hypersensitivity, prohibited meds.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Anti‑CD19 CAR‑T cells (autologous, gene‑modified cellular immunotherapy) following lymphodepleting chemotherapy (fludarabine, a purine‑analog antimetabolite, cyclophosphamide, an alkylating agent). Mechanism: Patient T cells are engineered with an FMC63‑derived anti‑CD19 scFv, CD8 hinge, TNFRSF19 transmembrane, 4‑1BB costimulatory, and CD3ζ signaling domains. CD19 engagement triggers T‑cell activation, proliferation, persistence, and cytotoxic killing (perforin/granzyme, cytokines). Lymphodepletion reduces host lymphocytes and tumor burden, creating space/cytokine milieu to enhance CAR‑T expansion. Targets: CD19‑expressing malignant B cells (DLBCL/NHL, CLL/Richter’s, ALL), T‑cell activation pathways (CD3ζ/TCR, 4‑1BB→NF‑κB), chemotherapy induces DNA damage/apoptosis in dividing lymphocytes. Phase 1, single‑arm, open‑label.