eligibility_summary
Adults ≥18 with CD19+ CLL/SLL, ≥2 prior regimens incl BTKi, measurable or flow+ disease. ECOG 0–1, adequate organs, EF≥50%, HBV/HCV–. ≥14 d since last systemic tx/steroids, ≥60 d since anti‑CD19. Contraception and biopsies. Exclude: prior CAR‑T/allo‑SCT, other trials, recent live vaccines/CPIs, HIV, active infection, major cardiac/pulm/autoimmune/neuro illness, anticoagulants (except aspirin), >5 mg prednisone, recent 2nd cancer, TLS/rhabdo/DKA/HHS.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I/II NIH trial in relapsed/refractory CLL/SLL testing autologous anti-CD19 CAR T cells (Hu19-CD828Z, fully human scFv with CD28–CD3ζ signaling). Patients receive lymphodepleting conditioning with rituximab (anti-CD20 monoclonal antibody), fludarabine (purine analog), and cyclophosphamide (alkylator) before CAR-T infusion. Mechanisms: the CAR redirects patient T cells to recognize CD19 on malignant B cells independent of MHC, triggering T-cell activation, proliferation, and cytotoxic killing, expected on-target effect is depletion of CD19+ cells (including normal B cells). Conditioning reduces tumor/host lymphocytes and augments CAR-T expansion, rituximab further debulks CD20+ B cells. Targets: CD19+ CLL/SLL cells, B-cell compartment, T-cell activation pathways via CD28/CD3ζ.