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

Официальное название

A Pilot Study of CAEL-101/Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement

Обзор

This is an exploratory study to assess the binding of CAEL-101/anselamimab to amyloid in vivo, recruitment of inflammatory cells and reduction of the amyloid mass.

Вмешательства

• Препарат Anselamimab
  Patients will receive anselamimab administered by intravenous infusion. The dose will be 1000 mg/m² based on body surface area (BSA) calculated from height and weight obtained during screening. BSA will not be recalculated unless body weight changes by ≥20% from screening. Study drug will be administered over approximately 2 hours. Participants will receive infusions every 7 (±1) days for the first 4 infusions, followed by every 14 (±2) days thereafter for a total treatment duration of 48 weeks

Первичные конечные точки

• Change From Baseline in Amyloid Target Lesion Size [Срок оценки: Baseline through Week 72]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Use of other investigational agents within 30 days of screening
• Taking doxycycline within 30 days of screening
• Current significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, or psychiatric disorder.
• Major surgery within 4 weeks of enrollment
• Pregnant
• Breast feeding
• Participant is eligible and agreeable to standard of care chemotherapy.
• Presence of active infection at the time of screening
• 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.
• AL amyloidoma involving other disease locations except those specified in the protocol
• Presence of solitary plasmacytoma
• Participant with clinically significant lung disorder or disease
• Not a candidate for definitive surgical treatment (i.e., complete resection) of amyloidoma.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Stanford University — Palo Alto

Идентификаторы

NCT: NCT07615270 · IRB-81617

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗