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Clinical Trial Details — Status: Available

Administrative data

NCT number NCT05776160
Other study ID # KT-US-471-0140
Secondary ID jRCT2033230370
Status Available
Phase
First received
Last updated

Study information

Verified date April 2024
Source Gilead Sciences
Contact Medical Information
Phone 844-454-5483(1-844-454-KITE)
Email medinfo@kitepharma.com
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial Summary

The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with a disease approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.


Recruitment information / eligibility

Status Available
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have commercially manufactured axicabtagene ciloleucel that does not meet commercial release criteria but does meet Kite clinical trial release criteria - Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been post-menopausal for at least 2 years are not considered to be of childbearing potential) - Deemed medically fit and stable to receive the product per the investigator's evaluation - Repeat leukapheresis is not feasible per the investigator's assessment - Be diagnosed with 1 of the approved labeled indications for axicabtagene ciloleucel that is intended for release - In the investigator's opinion, there is no satisfactory alternative therapy available to the individual Exclusion Criteria: - History of severe immediate hypersensitivity to any drugs or metabolites of similar chemical classes as axicabtagene ciloleucel - Uncontrolled active infection or inflammation per physician assessment - Primary central nervous system lymphoma

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Axicabtagene Ciloleucel
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.

Locations

Country Name City State
Japan Tokyo Medical And Dental University Hospital Bunkyo-ku
Japan Chiba University Hospital Chiba
Japan Hamanomachi Hospital Fukuokaken
Japan Gifu Municipal Hospital Gifu
Japan Hyogo Medical University Hospital Hyogo
Japan Kobe City Medical Center General Hospital Hyogo
Japan University of Tsukuba Hospital Ibaraki
Japan Kanazawa University Hospital Kanazawa
Japan Kumamoto University Hospital Kumamoto
Japan Kyoto University Hospital Kyoto
Japan University Hospital Kyoto Prefectural University of Medicine Kyoto
Japan Tohoku University Hospital Miyagi
Japan Shinshu University Hospital Nagano
Japan Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital Nagoya
Japan Nagoya University Hospital Nagoya
Japan Kurashiki Central Hospital Okayama
Japan Kansai Medical University Hospital Osaka
Japan Kindai University Hospital Osaka
Japan Osaka University Hospital Osaka
Japan Hokkaido University Hospital Sapporo Hokkaido
Japan Hamamatsu University Hospital Shizuoka
Japan Jichi Medical University Hospital Tochigi
Japan Jikei University Hospital Tokyo
Japan Juntendo University School of Medicine Juntendo Clinic Tokyo
Japan Keio University Hospital Tokyo
Japan National Cancer Center Hospital Tokyo
Japan The University of Tokyo Hospital Tokyo
Japan Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital Tokyo
Japan Toranomon Hospital Tokyo
Japan Yamagata University Hospital Yamagata
Japan Yokohama City University Hospital Yokohama
United States University of Michigan Ann Arbor Michigan
United States Winship Cancer Institute Atlanta Georgia
United States University of Maryland Cancer Center Baltimore Maryland
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Dana Farber Cancer Institute - Chestnut Hill Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States UNC Hospitals, The University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States Northwestern Memorial Hospital Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States The Ohio State University Wexner Medical Center- James Cancer Hospital Columbus Ohio
United States Colorado Blood Cancer Institute Denver Colorado
United States City of Hope Medical Center Duarte California
United States Banner MD Anderson Cancer Center Gilbert Arizona
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Sarah Cannon Research Institute Nashville Tennessee
United States University of Nebraska Medical Center Omaha Nebraska
United States UPMC Hillman Cancer Center Pittsburgh Pennsylvania
United States Oregon Health & Science University Portland Oregon
United States Virginia Commonwealth University Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States Washington University School of Medicine- Siteman Cancer Center Saint Louis Missouri
United States Methodist Healthcare System of San Antonio dba Methodist Hospital San Antonio Texas
United States Fred Hutchinson Cancer Center Seattle Washington
United States Avera Cancer Institute Sioux Falls South Dakota
United States The University of Kansas Medical Center Westwood Kansas

Sponsors (1)

Lead Sponsor Collaborator
Kite, A Gilead Company

Countries where clinical trial is conducted

United States,  Japan, 

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