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A Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01465139
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : June 27, 2017
Information provided by (Responsible Party):
Celldex Therapeutics

Brief Summary:
CDX-301 is a protein that stimulates the growth of bone marrow stem cells and certain immune cells. This study is testing CDX-301 in healthy volunteers who will be monitored for safety and biological response for approximately one month or more.

Condition or disease Intervention/treatment Phase
Healthy Drug: CDX-301 Phase 1

Detailed Description:

A total of seven cohorts of healthy volunteers are planned with doses of CDX-301 (rhuFlt3L) ranging between 1 and 75 μg/kg and dosing durations between 5 and 10 days.

Volunteers will be admitted to an inpatient unit during the Treatment Period. Blood samples will be collected periodically to assess the effect of CDX-301. Volunteers will be followed for safety for 28 days following the last dose. Any volunteer who develops anti-CDX-301 antibodies will be followed monthly until the antibody response is below the limit of detection. In general, the total duration of the study will be between approximately 33-38 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1 Safety, Pharmacokinetic, and Immunologic Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers
Study Start Date : October 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: CDX-301
CDX-301 (rhuFlt3L), administered to healthy patients.
Drug: CDX-301

CDX-301, administered in multiple dosages and frequencies depending on arm:

n=3-6 at between 1-75 μg/kg over 5 days

n=3-6 at 25 μg/kg over 7 days

n=3-6 at 25 μg/kg over 10 days

Primary Outcome Measures :
  1. Number of reported adverse events [ Time Frame: Until day 28 of follow up. ]
    The number of adverse events along with the results of vital sign measurements, physical examinations, and clinical laboratory tests will be used to determine the safety profile of CDX301.

Secondary Outcome Measures :
  1. Determination of PK profile of CDX301 [ Time Frame: Until day 28 of follow up or until resolution. ]
    Levels of CDX301 in circulating blood will be evaluated by measures such as AUC, Cmax, T1/2, and Tmax

  2. Immune system effects (eg: anti-CDX-301 antibody development, lymphoid cell populations, serum cytokines, and response to recall antigens and vaccination). [ Time Frame: Until day 28 of follow up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Among other criteria, volunteers must meet the following conditions to be eligible for the study:

  1. Ages 18 - 55
  2. Body Weight ≤ 120 kg
  3. Generally good health and without significant medical conditions
  4. Willing to use effective method of contraception
  5. Abstinence from alcohol for 72 hours prior to study drug administration and throughout the study
  6. Negative screening test for HIV, hepatitis B, and hepatitis C
  7. Provide written informed consent

Exclusion Criteria:

Among other criteria, volunteers who meet the following conditions are NOT eligible for the study:

  1. Drug or alcohol abuse within 12 months
  2. Positive drug screen
  3. Receipt of certain types of experimental drugs or other treatments, or certain medications
  4. Use of systemic immunosuppressive agents (excluding topical steroids) within 12 months
  5. History of certain diseases including syphilis, herpes zoster, primary or secondary immunodeficiency
  6. Diagnosis with or family history of significant autoimmunity (ex: type I diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma)
  7. Any history of cancer, excluding adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ within 2 years
  8. History of asthma requiring any use of inhaled or oral medication within 5 years
  9. Herpes zoster within 3 months
  10. Donation of blood within 8 weeks, and donation of plasma within 2 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01465139

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United States, New York
Rockefeller University
New York, New York, United States, 10065
Sponsors and Collaborators
Celldex Therapeutics
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Responsible Party: Celldex Therapeutics Identifier: NCT01465139    
Other Study ID Numbers: CDX301-02
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017