Phase 1/2, Open Label, Dose Escalation Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

Not Recruiting

Trial ID: NCT01707264

Purpose

Dose escalation study to determine the maximum tolerated dose of NEOD001 in approximately 30 subjects with AL amyloidosis. Expansion phase to evaluate safety, efficacy and pharmacokinetics of NEOD001 in 25 additional subjects at the maximum tolerated dose.

Official Title

A Phase 1/2, Open Label, Dose Escalation Study of Intravenous Administration of Single Agent NEOD001 in Subjects With Light Chain (AL) Amyloidosis

Stanford Investigator(s)

Rondeep Brar
Rondeep Brar

Clinical Associate Professor, Medicine - Hematology

Michaela Liedtke
Michaela Liedtke

Associate Professor of Medicine (Hematology)

Eligibility


Inclusion Criteria:

   1. Males and females aged ≥18 years;

   2. ECOG performance status (PS) 0-2;

   3. Diagnosis of systemic AL amyloidosis (subjects with non-AL amyloidosis are not
   eligible);

   4. Received at least one prior systemic therapy, which may include stem cell transplant,
   for AL amyloidosis;

   5. Have adequate organ function;

   6. Ability to understand and willingness to sign informed consent prior to initiation of
   any study procedures.

Exclusion Criteria:

   1. Secondary or familial amyloidosis;

   2. Life expectancy of < 3 months;

   3. Symptomatic multiple myeloma;

   4. Hypersensitivities to other monoclonal antibodies;

   5. Known HIV infection;

   6. Women who are lactating;

   7. Any other condition or prior therapy, which in the opinion of the PI, would make the
   subject unsuitable for the study.

Intervention(s):

drug: NEOD001

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061

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