A Pilot Study of Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement
A Pilot Study of CAEL-101/Anselamimab in Patients With AL Amyloidoma and Measurable Tissue Involvement
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Tidlig fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Mani Gupta
- Telefonnummer: 650-723-0501
- E-post: mgupta4@stanford.edu
Studiesteder
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California
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Palo Alto, California, Forente stater, 94305
- Stanford University
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Hovedetterforsker:
- Michaela Liedtke, MD
-
Ta kontakt med:
- Mani Gupta
- Telefonnummer: 650-723-0501
- E-post: mgupta4@stanford.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change From Baseline in Amyloid Target Lesion Size
Tidsramme: Baseline through Week 72
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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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Michaela Liedtke, MD, Stanford University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- IRB-81617
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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