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Not yet recruiting NCT07615270

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

Early Phase I Interventional AL Amyloidosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Anselamimab.
Who it may be relevant to
Registry conditions: AL Amyloidosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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

Primary outcome measures

  • Change From Baseline in Amyloid Target Lesion Size [Time frame: Baseline through Week 72]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Palo Alto

Identifiers

NCT: NCT07615270 · IRB-81617

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗