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New drug aims to shrink rare protein clumps in early trial

NCT ID NCT07615270

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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Conditions

The condition(s) this trial relates to.

AL amyloidosis Immunoglobulin Light-chain Amyloidosis

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.