eligibility_summary
Adults ≥18 with biopsy-proven AL amyloidosis (mass spec), monoclonal light chain, R/R after SOC (prior CD38 mAb or SCT allowed), measurable disease (dFLC ≥40 mg/L), SpO2 ≥92%, ECOG 0–2, contraception/compliance. Exclude: localized/non‑AL, multiple myeloma, recent active cancer, recent allo‑HSCT/GvHD, advanced cardiac disease (Mayo>3, NYHA>3, LVEF<40%, wall thickening), severe cytopenias, renal/hepatic dysfunction, high INR/aPTT, pregnancy, ≥G3 neuropathy, active infection, QTcF>480, unsafe risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05692908 (withdrawn): Phase 1 open-label 3+3 dose-escalation in relapsed/refractory systemic AL amyloidosis. Intervention: STI-6129, a biological anti-CD38 antibody–drug conjugate (ADC), also called anti-CD38–Duostatin 5.2. Mechanism: the anti-CD38 monoclonal antibody binds CD38 on clonal plasma cells, is internalized, and releases the Duostatin 5.2 cytotoxic payload to induce selective plasma-cell killing, aiming to lower pathogenic light-chain production and amyloid deposition. Target cells/pathway: CD38-expressing plasma cells (CD38 pathway) responsible for AL light-chain production. Dosing: IV every 4 weeks, 6 cohorts (0.88–3.68 mg/kg) to define MTD/RP2D. Status: withdrawn due to sponsor bankruptcy.