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

NCT01465139 | Completed Phase 1

• 1 other identifier: CDX301-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Determination of PK profile of CDX301

  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

Study Arms (1)

CDX-301

EXPERIMENTAL

CDX-301 (rhuFlt3L), administered to healthy patients.

Drug: CDX-301

Interventions

CDX-301 DRUG

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

CDX-301

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Among other criteria, volunteers must meet the following conditions to be eligible for the study:
• Ages 18 - 55
• Body Weight ≤ 120 kg
• Generally good health and without significant medical conditions
• Willing to use effective method of contraception
• Abstinence from alcohol for 72 hours prior to study drug administration and throughout the study
• Negative screening test for HIV, hepatitis B, and hepatitis C
• Provide written informed consent

You may not qualify if:

• Among other criteria, volunteers who meet the following conditions are NOT eligible for the study:
• Drug or alcohol abuse within 12 months
• Positive drug screen
• Receipt of certain types of experimental drugs or other treatments, or certain medications
• Use of systemic immunosuppressive agents (excluding topical steroids) within 12 months
• History of certain diseases including syphilis, herpes zoster, primary or secondary immunodeficiency
• Diagnosis with or family history of significant autoimmunity (ex: type I diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma)
• 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
• History of asthma requiring any use of inhaled or oral medication within 5 years
• Herpes zoster within 3 months
• Donation of blood within 8 weeks, and donation of plasma within 2 weeks

Sponsors & Collaborators

• Celldex Therapeutics: lead

Study Sites (1)

Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (1)

• 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.

  PMID: 25915810 BACKGROUND

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: November 4, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

US (1)