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


About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Morie Gertz, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


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