<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04452994</url>
  </required_header>
  <id_info>
    <org_study_id>CR108848</org_study_id>
    <nct_id>NCT04452994</nct_id>
  </id_info>
  <brief_title>Individual Patient Investigational New Drug (IND) Expanded Access Program of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Participant With Multiple Myeloma</brief_title>
  <official_title>Individual Patient IND Expanded Access Program JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy for Patient J.M. With Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Janssen Research &amp; Development, LLC</source>
  <brief_summary>
    <textblock>
      The purpose of this individual-patient investigational new drug (IND) single patient request&#xD;
      (SPR) is to provide participants treatment with JNJ-68284528, an investigational product&#xD;
      prior to its marketing authorization. Such access may be considered for participants with&#xD;
      serious/life-threatening diseases or conditions, where there exists no alternative treatments&#xD;
      or where alternative treatments have been exhausted.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>No longer available</overall_status>
  <study_type>Expanded Access</study_type>
  <has_expanded_access>No</has_expanded_access>
  <expanded_access_info>
    <expanded_access_type_individual>Yes</expanded_access_type_individual>
  </expanded_access_info>
  <condition>Multiple Myeloma</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>JNJ-68284528</intervention_name>
    <description>JNJ-68284528 will be administered as a single intravenous (IV). The target dose will be the recommended Phase 2 dose (RP2D) of 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg) (range: 0.5 to 1.0*10^6 CAR-positive viable T cells/kg).</description>
  </intervention>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04452994
org study id: CR108848
nct id: NCT04452994
lead sponsor: 
The purpose of this individual-patient investigational new drug (IND) single patient request
      (SPR) is to provide participants treatment with JNJ-68284528, an investigational product
      prior to its marketing authorization. Such access may be considered for participants with
      serious/life-threatening diseases or conditions, where there exists no alternative treatments
      or where alternative treatments have been exhausted.
expanded access type individual: Yes
intervention type: Drug
intervention name: JNJ-68284528
description: JNJ-68284528 will be administered as a single intravenous (IV). The target dose will be the recommended Phase 2 dose (RP2D) of 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg) (range: 0.5 to 1.0*10^6 CAR-positive viable T cells/kg).
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell