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



Status:Completed
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:8/30/2018
Start Date:April 2013
End Date:August 9, 2016

Use our guide to learn which trials are right for you!

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

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.

The purpose of the dose escalation phase of the study is to determine the maximum tolerated
dose/Phase 2 recommended dose of NEOD001 when given as a single agent intravenously in
approximately 30 subjects with AL amyloidosis.

The purpose of the expansion phase of the study is to evaluate the safety, preliminary
efficacy and pharmacokinetics of single agent NEOD001 at the maximum tolerated dose/Phase 2
recommended dose in approximately 25 additional evaluable subjects.

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.
We found this trial at
7
sites
800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
?
mi
from
Boston, MA
Click here to add this to my saved trials
72 East Concord Street
Boston, Massachusetts 02118
(617) 638-5300
Boston University School of Medicine A leader in medical education and research, Boston University School...
?
mi
from
Boston, MA
Click here to add this to my saved trials
3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
?
mi
from
New York, NY
Click here to add this to my saved trials
Palo Alto, California 94305
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials