eligibility_summary
Adults (>=18) with CD19+ CLL/SLL after >=1 prior regimen, on ibrutinib >=3 months without >=grade 2 non-hematologic toxicity, ECOG 0–1, adequate organs (Cr<1.6, AST/ALT<3x ULN, bili<2.0 or Gilbert exception), LVEF>50%, >6 months post-transplant, no GVHD, eligible for leukapheresis. Exclude: Richters, pregnancy/lactation, uncontrolled infection or medical disorder, active HBV/HCV, HIV, steroids/immunosuppression, CNS disease, NYHA III/IV, unstable arrhythmias.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I/II single-arm trial testing concomitant autologous anti-CD19 CAR T cells and lenalidomide in relapsed/refractory CLL/SLL after a 3-month ibrutinib run-in. CAR T: gene-modified cellular therapy using IL-7/IL-15–expanded T cells expressing a CD19-specific scFv with 4-1BB/CD3ζ signaling domains. Mechanism: redirects T cells to CD19+ malignant B cells for cytotoxic killing, 4-1BB enhances expansion/persistence. Lenalidomide: immunomodulatory drug (IMiD) that binds cereblon (CRL4) to degrade Ikaros/Aiolos, boosting T- and NK-cell activation and cytokine production, also given as 3-month maintenance. Supportive: fludarabine/cyclophosphamide lymphodepletion, ibrutinib (BTK inhibitor) reduces BCR signaling and may improve T-cell fitness. Targets/pathways: CD19+ B cells, T-cell activation/persistence (CD3ζ, 4-1BB, IL-7/IL-15), cereblon pathway, BTK/BCR signaling.