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Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

Primary Purpose

Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Brexucabtagene Autoleucel
Sponsored by
Kite, A Gilead Company
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Mantle Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Have commercially manufactured brexucabtagene autoleucel 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 brexucabtagene autoleucel 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 brexucabtagene autoleucel Uncontrolled active infection or inflammation per physician assessment Primary central nervous system (CNS) lymphoma

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    March 3, 2023
    Last Updated
    June 5, 2023
    Sponsor
    Kite, A Gilead Company
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05776134
    Brief Title
    Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
    Official Title
    Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Kite, A Gilead Company

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mantle Cell Lymphoma, Acute Lymphoblastic Leukemia

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    Brexucabtagene Autoleucel
    Other Intervention Name(s)
    Tecartus™
    Intervention Description
    A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Eligibility Criteria
    Inclusion Criteria: Have commercially manufactured brexucabtagene autoleucel 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 brexucabtagene autoleucel 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 brexucabtagene autoleucel Uncontrolled active infection or inflammation per physician assessment Primary central nervous system (CNS) lymphoma
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Medical Information
    Phone
    844-454-5483(1-844-454-KITE)
    Email
    medinfo@kitepharma.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kite Study Director
    Organizational Affiliation
    Kite, A Gilead Company
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    https://www.gileadclinicaltrials.com/study/?id=KT-US-472-0141
    Description
    Gilead Clinical Trials Website

    Learn more about this trial

    Expanded Access Study for the Treatment of Patients With Commercially Out-of-Specification Brexucabtagene Autoleucel

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