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(NAN-0756) CDX-301 in Healthy Volunteers

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A Phase 1 Safety, Pharmacokinetic, and Immunologic Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers

Principal Investigator:
Niroshana Anandasabapathy M.D., Ph.D.

Bryan Yipp MD
Christine Trumpfheller Ph.D.
Sarah Schlesinger M.D.
Sarah Pollak RN
Barbara O'Sullivan MD, MPH
Saurabh Mehandru M.D.
Arlene Hurley ANP-BC
Marina Caskey M.D.
Gaelle Breton MSc

Contact Information:
Clinical Research Support Office
The Rockefeller University
1230 York Ave.
New York, NY
Telephone: 1-800-RUCARES
Enrollment Status:
Closed to Enrollment

Brief Summary of Protocol:
The reason for doing this research is to study a new investigational agent called CDX-301 and its effects on blood cells and help to determine the best dose of this agent for future studies. An investigational agent is one that is not approved by the U.S. Food and Drug Administration (FDA) for use by the general public. We have told the FDA about this study, and it has allowed this agent to be used in this study. This study agent is similar to a hormone in that it is very much like a natural substance called Flt3 ligand that is already found in your bone marrow. In your body, Flt3 ligand helps certain types of blood cells to develop and grow, such as blood stem cells. It also may influence how your body responds to infections. This study is designed to help us determine whether CDX-301 might be helpful for people with cancer, or to improve vaccines, including whether it may be potentially valuable in stem cell transplantation for patients with cancer, or it may help the ability of vaccines to treat cancer or infectious diseases. This is the first time that CDX-301 will be tested in people.

Detailed Description of Protocol:
About 27- 42 people will take part in the research study at the Rockefeller University. There are two screening visits to determine your eligibility. If you join the research study, you will take part for about 9 weeks (which includes screening). Participation requires that you stay in the hospital for 5, 7 or 10 days depending on which group you are enrolled in. The research study as a whole will last about 9 months.

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

- In good health
- Body Mass Index (BMI) between 18 and 30



Children permitted to participate:

Potential Benefits.....
There will be no benefit to you. Instead, others may benefit in the future from what we learn from this study.

Compensation is provided for study participation.