A Safety Study of SYNT001 in Subjects With Chronic, Stable Warm Autoimmune Hemolytic Anemia (WAIHA)

Description

This study is being conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and effects on warm autoimmune hemolytic anemia (WAIHA) disease activity markers of intravenous (IV) SYNT001.

Study Start Date

October, 01 2017

Estimated Completion Date

March 2018

Interventions

  • Drug: SYNT001

Study ID

Syntimmune, Inc. -- SYNT001-102

Status

Unknown

Trial ID

NCT03075878

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

16

Sponsor

Syntimmune, Inc.

Inclusion Criteria

    Subjects must meet the following criteria to be included:
  • Willing and able to read, understand and sign an informed consent form
  • Confirmed diagnosis by enrolling physician of WAIHA
  • Must use medically acceptable contraception

Exclusion Criteria

    Subjects meeting any of the following criteria are to be excluded:
  • Subject unable or unwilling to comply with the protocol
  • Active non-hematologic malignancy or history of non-hematologic malignancy in the 3 years prior to screening (exclusive of non-melanoma skin cancer and cervical cancer in situ)
  • Positive for HIV or hepatitis C antibody
  • Positive for hepatitis B surface antigen
  • Any exposure to an investigational drug or device within the 30 days prior to screening
  • IVIG treatment within 60 days of screening
  • Plasmapheresis or immunoadsorption within 60 days of screening
  • Subject has any current medical condition that, in the opinion of the Investigator, may compromise their safety or compliance, preclude successful conduct of the study, or interfere with interpretation of the results

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (23)

Study Location Distance Name Phone Email
Massachusetts General Hospital Cancer Center - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital Cancer Center - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital Cancer Center - Boston, Massachusetts 2.8 miles None None None
Massachusetts General Hospital Cancer Center - Boston, Massachusetts 2.8 miles None None None
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles None None None
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles None None None
Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles None None None
Cleveland Clinic Taussig Cancer Center - Cleveland, Ohio 544.0 miles None None None
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles None None None
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles None None None
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles None None None
Mayo Clinic Rochester - Rochester, Minnesota 1,083.1 miles None None None
University of Washington Medical Center - Seattle, Washington 2,487.7 miles None None None
University of Washington Medical Center - Seattle, Washington 2,487.7 miles None None None
University of Washington Medical Center - Seattle, Washington 2,487.7 miles None None None
USC Norris Comprehensive Cancer Center - Los Angeles, California 2,593.7 miles None None None
USC Norris Comprehensive Cancer Center - Los Angeles, California 2,593.7 miles None None None
USC Norris Comprehensive Cancer Center - Los Angeles, California 2,593.7 miles None None None
USC Norris Comprehensive Cancer Center - Los Angeles, California 2,593.7 miles None None None
University of California San Francisco Outpatient Hematology ClinicInfusion Center - San Francisco, California 2,699.8 miles None None None
University of California San Francisco Outpatient Hematology ClinicInfusion Center - San Francisco, California 2,699.8 miles None None None
University of California San Francisco Outpatient Hematology ClinicInfusion Center - San Francisco, California 2,699.8 miles None None None
University of California San Francisco Outpatient Hematology ClinicInfusion Center - San Francisco, California 2,699.8 miles None None None

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