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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07615270
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • AL Amyloidosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Change From Baseline in Amyloid Target Lesion Size [ Time Frame: Baseline through Week 72 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94305
Mani Gupta
[email protected]
650-723-0501
Michaela Liedtke, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University· Palo Alto, CA

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