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Not yet recruitingNCT07615270Updated Aug 21, 2026

A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement

An Early Phase 1 interventional study of Anselamimab in AL Amyloidosis, sponsored by Stanford University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-21.

Sponsored by Stanford University · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • AL Amyloidosis

Keywords

  • Anselamimab
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (estimated)

Study arms

  • Experimental
    Anselamimab

    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.

    Drug: Anselamimab

Interventions

  • DrugAnselamimab

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline through Week 72

06

Study locations

1 site
  • Stanford University
    Palo Alto, California 94305, United States
    • Mani Gupta · Contact · mgupta4@stanford.edu · 650-723-0501
    • Michaela Liedtke, MD · Principal investigator
07

Registry details

Key details

Study ID
NCT07615270
Lead sponsor
Stanford University
Responsible party
Sponsor
First posted
May 29, 2026
Start date
Sep 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Aug 21, 2026

Study contacts

Mani Gupta
Contact
mgupta4@stanford.edu
650-723-0501
Michaela Liedtke, MD
principal investigator · Stanford University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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