AL AmyloidosisEarly Phase 1NCT07615270
A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement
A Early Phase 1 study testing Anselamimab in people with AL Amyloidosis, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AL Amyloidosis
- What is being tested?
- Anselamimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jul 2028
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Palo Alto, California, 94305
Mani Gupta, 650-723-0501, mgupta4@stanford.edu
Michaela Liedtke, MD
About this study
Official title: A Pilot Study of CAEL-101/Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement
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.
- Conditions
- AL Amyloidosis
- Being tested
- Anselamimab
- Keywords
- Anselamimab
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnselamimabDrug
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. The maximum single dose is 2700 mg.
Participants will be monitored for infusion-related reactions and overall tolerability for approximately 90 minutes following completion of the first 4 infusions, or longer at the investigator's discretion.
Premedication with diphenhydramine (25-50 mg PO/IV), acetaminophen/paracetamol (325-650 mg PO/IV), and/or similar agents may be administered per institutional standards to reduce the risk of infusion-related reactions.
| Study group | Role | What they receive |
|---|---|---|
| Anselamimab | Experimental | Participants will receive anselamimab (CAEL-101) 1000 mg/m² by IV infusion weekly for 4 infusions, then every 2 weeks thereafter for up to 48 weeks. Premedication for infusion reaction prophylaxis may be administered according to institutional standards. Receives: Drug: Anselamimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Amyloid Target Lesion Size
Amyloid target lesion size will be assessed using RECIST v1.1 criteria. Measurements will be obtained at baseline and at Weeks 12, 24, 36, 48, and 72. The outcome will evaluate change from baseline in target lesion size.
Measured: Baseline through Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startSep 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AL AmyloidosisStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michaela Liedtke, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615270
- Sponsor's protocol ID
- IRB-81617
- Status last verified
- Aug 2026
- First submitted
- 22 May 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No