A Pilot Study of Anselamimab in Patient… | Clinical Trial

Key information

Conditions

AL Amyloidosis Amyloidosis Immune System Diseases Immunoglobulin Light-chain Amyloidosis Immunoproliferative Disorders Lymphoproliferative Disorders Metabolic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Nutritional and Metabolic Diseases Paraproteinemias Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Stanford University

Palo Alto, California, 94305, United States

Location contact

Mani Gupta

CONTACT

[email protected]

650-723-0501

Michaela Liedtke, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anselamimab

Drug

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.

Primary outcomes

Change From Baseline in Amyloid Target Lesion Size

Time frame: Baseline through Week 72

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mani Gupta

CONTACT

[email protected]

650-723-0501

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

A Pilot Study of CAEL-101/Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: May 29, 2026
Registry last updated: May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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