NCT07615270Not yet recruitingEarly phase 1
A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement
A Pilot Study of CAEL-101/Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement
Source: ClinicalTrials.gov · Last updated 27 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- First submitted
- 22 May 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Stanford University
- Diseases
- Amyloidosis
- NCT number
- NCT07615270
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 5
- From 1 Sept 2026 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stanford University Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.