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

• Status: Completed
• Trial end date: 2016-08-09
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prothena Biosciences Ltd.; Prothena Therapeutics Ltd.

Criteria

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.