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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CDX-301

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Rockefeller University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of reported adverse events	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.	Until day 28 of follow up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of PK profile of CDX301	Levels of CDX301 in circulating blood will be evaluated by measures such as AUC, Cmax, T1/2, and Tmax	Until day 28 of follow up or until resolution.
Immune system effects (eg: anti-CDX-301 antibody development, lymphoid cell populations, serum cytokines, and response to recall antigens and vaccination).		Until day 28 of follow up

Collaborators and Investigators

• Sponsor: Celldex Therapeutics

Publications and helpful links

General Publications

• Anandasabapathy N, Breton G, Hurley A, Caskey M, Trumpfheller C, Sarma P, Pring J, Pack M, Buckley N, Matei I, Lyden D, Green J, Hawthorne T, Marsh HC, Yellin M, Davis T, Keler T, Schlesinger SJ. Efficacy and safety of CDX-301, recombinant human Flt3L, at expanding dendritic cells and hematopoietic stem cells in healthy human volunteers. Bone Marrow Transplant. 2015 Jul;50(7):924-30. doi: 10.1038/bmt.2015.74. Epub 2015 Apr 27.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 13, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimate): November 4, 2011

Study Record Updates

• Last Update Posted (Actual): June 27, 2017
• Last Update Submitted That Met QC Criteria: June 26, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CDX301-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No