Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
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:
No evidence of cardiac, renal or hepatic involvement by amyloidosis
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mani Gupta | Contact | 650-723-0501 | mgupta4@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michaela Liedtke, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | United States |
Not provided
| ID | Term |
|---|---|
| D000075363 | Immunoglobulin Light-chain Amyloidosis |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000686 | Amyloidosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D057165 |
| Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010265 | Paraproteinemias |