A Phase 2 Clinical Trial of Teclistamab and Daratumumab in Previously Untreated AL Amyloidosis
The purpose of this study is to investigate whether teclistamab-daratumumab combination is effective and safe in AL amyloidosis. The study treatment is divided into cycles (C) and each cycle is 28 days (D). Study treatment is expected to last 6 months.
• Age \>18 years and able to sign Informed Consent Form (ICF). If the individual being considered for participation in this study is unable to provide informed consent due to medical, cognitive, or other conditions, a legally authorized representative (LAR) may consent on their behalf.
• Ability to comply with the study protocol, in the investigator's judgment.
• Confirmed histopathological diagnosis of systemic AL amyloidosis by mass spectrometry or immunohistochemistry (IHC) or Immunofluorescence (IF) on a tissue biopsy that is positive for Congo Red.
• Patient must not have received any prior plasma cell clone-directed therapy.
• Measurable hematologic disease, defined as one of the following:
‣ Difference between involved and uninvolved serum free light chain (dFLC) ≥50 mg/L and/or 5 mg/dL
⁃ Serum M-protein ≥0.5 g/dL on protein electrophoresis
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• One or more organs involved by AL amyloidosis as per consensus guidelines
• Pre-treatment clinical laboratory values meeting the following criteria during the screening phase:
‣ Absolute neutrophil count ≥0.75 × 10\^9/L
⁃ Hemoglobin level ≥8.0 g/dL; red blood cell transfusion allowed until 7 days before C1D0.
⁃ Platelet count ≥50 × 10\^9/L; Platelet transfusions are acceptable without restriction during the Screening period
⁃ Alanine aminotransferase level (ALT) ≤2.5 times the Upper Limit of Normal (ULN)
⁃ Aspartate aminotransferase (AST) ≤2.5 times the ULN
⁃ Total bilirubin level ≤1.5 × ULN except for subjects with Gilbert syndrome, in which case direct bilirubin ≤2 × ULN
⁃ Estimated glomerular filtration rate (eGFR) ≥20 mL/min/1.73 m\^2, measured by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs.
∙ For men: Agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.