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

NCT07615270 | Not Yet Recruiting Early Phase 1 FDA Drug

• 1 other identifier: IRB-81617
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AL Amyloidosis

Keywords

Anselamimab

Outcome Measures

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.

  Baseline through Week 72

Study Arms (1)

Anselamimab

EXPERIMENTAL

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

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.

Anselamimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AL amyloid deposit confirmed by biopsy and IHC or mass spectrometry
• Amyloid deposits are measurable by imaging (ultrasound or cross-sectional)
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

Location

MeSH Terms

Conditions

Immunoglobulin Light-chain Amyloidosis

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Amyloidosis; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Paraproteinemias

Study Officials

• Michaela Liedtke, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mani Gupta

CONTACT

650-723-0501; mgupta4@stanford.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

US (1)