A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement

Korábbi kezelés

• Use of other investigational agents within 30 days of screening
• Major surgery within 4 weeks of enrollment
• Participant is eligible and agreeable to standard of care chemotherapy.
• Not a candidate for definitive surgical treatment (i.e., complete resection) of amyloidoma.

Más betegség

• Current significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, or psychiatric disorder.
• Presence of active infection at the time of screening
• AL amyloidoma involving other disease locations except those specified in the protocol
• Participant with clinically significant lung disorder or disease

Egyéb

• Taking doxycycline within 30 days of screening
• Pregnant
• Breast feeding
• Participant with a monoclonal protein or isotypic light chain predominance (increased level of the involved light chain and abnormal free light chain ratio (<0.26 or >1.65)) ☐
  • ☐
• Participant with known or suspected systemic AL amyloidosis, or suspicion of other organ involvement.
• Lymph node involvement
• Involvement of amyloidoma in more than one organ.
• Presence of solitary plasmacytoma

• AL amyloid deposit confirmed by biopsy and IHC or mass spectrometry
• Amyloid deposits are measurable by imaging (ultrasound or cross-sectional)
• 18 years or older
• ECOG performance status 0-3
• Adequate bone marrow reserve, hepatic and renal function as demonstrated by:
  • Absolute neutrophil count ≥ 1.0 × 109/L
  • Platelet count ≥ 75 × 109/L
  • Hemoglobin ≥ 9 g/dL
  • Total bilirubin ≤ 2 times the upper limit of normal (× ULN) unless due to Gilbert's syndrome.
  • Aspartate aminotransferase (AST) ≤ 3 × ULN
  • Alanine aminotransferase (ALT) ≤ 3 × ULN
• No evidence of cardiac, renal or hepatic involvement by amyloidosis
  • Echocardiogram with mean wall thickness </= 12mm unless other cardiac cause
  • 24 hour urine protein <500mg AND estimated glomerular filtration rate (eGFR) >50mL/min/1.73 sqm (Cockcroft-Gault formula)
  • Alkaline phosphatase below upper limit of normal and total liver span </=15cm
• Participants of childbearing potential agree to use contraception throughout study an
• Ability to understand and willingness to provide written informed consent.