xml: <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/NCT05980507</url>
    </required_header>
    <id_info>
      <org_study_id>CICI201Y001</org_study_id>
      <nct_id>NCT05980507</nct_id>
    </id_info>
    <brief_title>An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma</brief_title>
    <official_title>An Open Label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ICI201 Infusion in Relapsed/Refractory Multiple Myeloma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The First Affiliated Hospital of Soochow University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The First Affiliated Hospital of Soochow University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        An open label, single-arm clinical study evaluating the safety and efficacy of ICI201&#xD;
        infusion in relapsed/refractory multiple myeloma&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 9, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Dose limiting toxicity (DLT)</measure>
      <time_frame>Time Frame: 28 days post ICI201 administration</time_frame>
      <description>Dose limiting toxicity (DLT)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence and severity of all adverse events related to study drug</measure>
      <time_frame>Time Frame: 2 years post ICI201 administration</time_frame>
      <description>Incidence and severity of all adverse events related to study drug</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Relapsed/Refractory Multiple Myeloma</condition>
    <arm_group>
      <arm_group_label>ICI201</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>ICI201</intervention_name>
      <description>ICI201 CAR-T cell injection</description>
      <arm_group_label>ICI201</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. According to the multiple myeloma diagnostic criteria of the International Myeloma&#xD;
               Working Group (IMWG), there is the initial diagnosis of multiple myeloma. 2. Subjects&#xD;
               must have previously received at least 3 anti-myeloma regimens. Subjects must have&#xD;
               documented disease progression (according to IMWG criteria) during or within 12 months&#xD;
               of completing their last anti-myeloma regimen prior to study entry; and prior regimens&#xD;
               must have included proteasome inhibitor (PI) and immunomodulatory drug (IMiD). 3.&#xD;
               Measurable disease as defined by the protocol 4. ECOG score is 0 or 1. 5. Expected&#xD;
               survival time ≥12 weeks. 6. GPRC5D positive expression in bone marrow plasma cells&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Patients suffering from graft-versus-host disease (GVHD) or requiring&#xD;
               immunosuppressants drugs. 2. Patients who received autologous hematopoietic stem cell&#xD;
               transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation&#xD;
               (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection. 3. Screening&#xD;
               subjects who were receiving systemic steroids during the previous 7 days or who were&#xD;
               determined by the investigator to require long-term systemic steroid use during&#xD;
               treatment (except for inhaled or topical use, except at doses &lt; 10mg/ day). 4.&#xD;
               Patients with a history of hypertension that cannot be controlled by medication (blood&#xD;
               pressure ≥140/90 mmHg). 5. Patients who have recieved GPRC5D-targeted therapy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>First Affiliated Hospital, Soochow University</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <zip>215000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</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>
  
  
text: 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/NCT05980507
  org study id: CICI201Y001
  nct id: NCT05980507
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  An open label, single-arm clinical study evaluating the safety and efficacy of ICI201
        infusion in relapsed/refractory multiple myeloma
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Dose limiting toxicity (DLT)
  time frame: Time Frame: 28 days post ICI201 administration
  description: Dose limiting toxicity (DLT)
  measure: Incidence and severity of all adverse events related to study drug
  time frame: Time Frame: 2 years post ICI201 administration
  description: Incidence and severity of all adverse events related to study drug
  arm group label: ICI201
  arm group type: Experimental
  intervention type: Drug
  intervention name: ICI201
  description: ICI201 CAR-T cell injection
  arm group label: ICI201
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell