eligibility_summary
Eligible: CLL/SLL per IwCLL/WHO, on acalabrutinib ≥3 months without progression, relapsed/refractory with ≥1 prior therapy, MRD+ by clonoSEQ, adequate organ and marrow function. Exclude: CNS disease, no clonoSEQ ID, recent anticancer therapy or HSCT, BTKi progression or acalabrutinib intolerance, pregnancy/breastfeeding, major illness/infection, immunosuppression or ≥10 mg prednisone, recent SOT, significant effusions, hypersensitivity to loncastuximab, other active malignancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I (BOIN design) trial adding loncastuximab tesirine to fixed-dose acalabrutinib in CLL/SLL patients already on acalabrutinib. Interventions: loncastuximab tesirine—an anti-CD19 antibody-drug conjugate (ADC) that binds CD19 on B cells, is internalized, and releases a pyrrolobenzodiazepine (PBD) DNA–crosslinking cytotoxin causing apoptosis, acalabrutinib—a covalent small‑molecule Bruton’s tyrosine kinase (BTK) inhibitor that blocks B‑cell receptor signaling, reducing proliferation/survival. Targets: CD19+ malignant B cells, pathways: BTK/BCR signaling and DNA integrity. Aim: determine MTD to deepen responses/clear MRD.