ClinicalTrials.gov record NCT07615270
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
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This is an early-phase (pilot) interventional study testing the drug anselamimab (CAEL-101) in adults with AL amyloidoma and measurable tissue lesions. All participants receive IV anselamimab on a set schedule (weekly for four doses, then every two weeks) for up to 48 weeks in a single-group, open-label design. The study uses imaging to measure changes in lesion size through Week 72. It is exploratory and aims to assess drug binding, inflammation recruitment, and changes in amyloid mass.
What it is studying. The study tests whether anselamimab binds to amyloid deposits in the body, whether inflammatory cells are recruited to the deposits, and whether the amyloid mass (lesion size) changes after treatment. The primary measurement is change from baseline in target lesion size using RECIST v1.1 on imaging at baseline and at Weeks 12, 24, 36, 48, and 72.
What the researchers hope to learn. Scientific goals: to assess in vivo binding of CAEL-101/anselamimab to amyloid, to evaluate recruitment of inflammatory cells to deposits, and to measure changes in amyloid mass (lesion size) over time.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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 being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Anselamimab
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive intravenous anselamimab (1000 mg/m²) infusions over about 2 hours weekly for the first 4 doses, then every 14 days thereafter for up to 48 weeks (maximum single dose 2700 mg). Infusions include monitoring for infusion-related reactions and about 90 minutes of observation after the first four infusions; standard premedication (for example, diphenhydramine and/or acetaminophen) may be used. The study includes repeated imaging to measure lesion size at baseline and Weeks 12, 24, 36, 48 and 72, plus routine blood tests and safety assessments. Screening will confirm eligibility (including review of biopsy results and laboratory tests) and you must provide written informed consent.
How the study is structured. Interventional, open-label, single-group early Phase 1 pilot study. Every participant receives IV anselamimab (1000 mg/m²) given approximately over 2 hours weekly for the first four infusions, then every two weeks thereafter for up to 48 weeks. Participants are monitored for infusion reactions and tolerability; lesion size is followed by imaging through Week 72.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on AL amyloidosis
Important dates
- Study start
- September 2026 (estimated)
- Primary completion
- July 2028 (estimated)
- Study completion
- July 2028 (estimated)
- Target enrollment
- 5 participants (estimated)
- Last updated on registry
- Aug 21, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Stanford University
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Mani Gupta 📞 650-723-0501 ✉ mgupta4@stanford.edu
Participating sites (1)
- Stanford University
Palo Alto, California, 94305 · United States
- Mani Gupta · 650-723-0501 · mgupta4@stanford.edu
- Michaela Liedtke, MD
Terms used on this page · explanations by MedicalUpdates.ai
- biopsy
- Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
- ECOG performance status
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- Absolute neutrophil count
- The number of neutrophils, a type of white blood cell that fights infection, in a blood sample. Studies often require it to be above a set level.
- upper limit of normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- Echocardiogram
- An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
- estimated glomerular filtration rate
- A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
- Cockcroft-Gault
- A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- investigational
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- standard of care
- Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
- free light chain
- Small pieces of antibody protein made by plasma cells and measured in a blood test. In some conditions, such as AL amyloidosis, abnormal free light chains are the source of the disease.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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