New drug aims to shrink rare protein clumps in early trial
NCT ID NCT07615270
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This early study tests whether the drug CAEL-101/anselamimab can bind to and shrink abnormal protein deposits (amyloid) in people with AL amyloidoma. Five adults with measurable amyloid deposits will receive the drug and be monitored for up to 72 weeks. The goal is to see if the deposits get smaller, not to cure the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Jul 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. AL amyloid deposit confirmed by biopsy and IHC or mass spectrometry 2. Amyloid deposits are measurable by imaging (ultrasound or cross-sectional) 3. 18 years or older 4. ECOG performance status 0-3 5. Adequate bone marrow reserve, hepatic and renal function as demonstrated by: 1. Absolute neutrophil count ≥ 1.0 × 109/L 2. Platelet count ≥ 75 × 109/L 3. Hemoglobin ≥ 9 g/dL 4. Total bilirubin ≤ 2 times the upper limit of normal (× ULN) unless due to Gilbert's syndrome. 5. Aspartate aminotransferase (AST) ≤ 3 × ULN 6. Alanine aminotransferase (ALT) ≤ 3 × ULN 6. No evidence of cardiac, renal or hepatic involvement by amyloidosis 1. Echocardiogram with mean wall thickness \</= 12mm unless other cardiac cause 2. 24 hour urine protein \<500mg AND estimated glomerular filtration rate (eGFR) \>50mL/min/1.73 sqm (Cockcroft-Gault formula) 3. Alkaline phosphatase below upper limit of normal and total liver span \</=15cm 7. Participants of childbearing potential agree to use contraception throughout study an 8. Ability to understand and willingness to provide written informed consent. Exclusion Criteria: 1. Use of other investigational agents within 30 days of screening 2. Taking doxycycline within 30 days of screening 3. Current significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders, or psychiatric disorder. 4. Major surgery within 4 weeks of enrollment 5. Pregnant 6. Breast feeding 7. Participant is eligible and agreeable to standard of care chemotherapy. 8. Presence of active infection at the time of screening 9. 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)) ☐ ☐ 10. Participant with known or suspected systemic AL amyloidosis, or suspicion of other organ involvement. 11. Lymph node involvement 12. Involvement of amyloidoma in more than one organ. 13. AL amyloidoma involving other disease locations except those specified in the protocol 14. Presence of solitary plasmacytoma 15. Participant with clinically significant lung disorder or disease 16. Not a candidate for definitive surgical treatment (i.e., complete resection) of amyloidoma.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Al amyloidosis are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Stanford University
Palo Alto, California, 94305, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Dual-Targeting antibody stop amyloid buildup in its tracks?
- Can a radioactive peptide spot hidden amyloid in the heart?
- Real-world data on multiple myeloma immunotherapies could reshape monitoring and improve survival
- Nationwide registry aims to crack the code of a rare protein-clogging disease
- New scan spots hidden organ damage before symptoms start
- Could a simple scan unlock better heart treatment?