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/NCT06038474</url>
    </required_header>
    <id_info>
      <org_study_id>DC08-SLE-001</org_study_id>
      <nct_id>NCT06038474</nct_id>
    </id_info>
    <brief_title>Descartes-08 for Patients With Systemic Lupus Erythematosus</brief_title>
    <acronym>SLE-001</acronym>
    <official_title>Descartes-08 for Patients With Systemic Lupus Erythematosus</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cartesian Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cartesian Therapeutics</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a Phase II study to evaluate the safety, tolerability and manufacturing feasibility&#xD;
        of Descartes-08 CAR T-cells in patients with Systematic Lupus erythematosus (SLE).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">November 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2025</primary_completion_date>
    <phase>Phase 2</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>Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE)</measure>
      <time_frame>Day -59 to Day 50</time_frame>
      <description>Results will be descriptive. Safety and tolerability endpoints will include descriptive statistics of AEs and SAEs. Patients must be followed until all AEs have resolved to Grade 2 or less except for lymphopenia and alopecia.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)</measure>
      <time_frame>Day -59 to Month 12</time_frame>
      <description>Assessment of Systemic Lupus Erythematosus Disease Activity Index 2000 from baseline administration at various timepoints up to month 12 follow up visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI)</measure>
      <time_frame>Day -59 to Month 12</time_frame>
      <description>Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at various timepoints up to month 12 follow up visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantify the clinical activity of Descartes-08 in patients with SLE using British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA)</measure>
      <time_frame>Day -59 to Month 12</time_frame>
      <description>Assessment of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) at various timepoints up to month 12 follow up visit.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quantify the clinical activity of Descartes-08 in patients with SLE using Physician Global Assessment (PGA)</measure>
      <time_frame>Day -59 to Month 12</time_frame>
      <description>Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Systemic Lupus Erythematosus (SLE)</condition>
    <arm_group>
      <arm_group_label>Descartes-08</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Drug: Descartes-08&#xD;
  Autologous T-cells expressing a chimeric antigen receptor directed to BCMA</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Descartes-08</intervention_name>
      <description>Autologous T-cells expressing a chimeric antigen receptor directed to BCMA</description>
      <arm_group_label>Descartes-08</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient must be at least 18 years of age.&#xD;
  &#xD;
            -  Patient must have systemic lupus erythematosus (SLE) at the time of screening.&#xD;
  &#xD;
            -  Active symptoms despite recent or ongoing immunosuppressive therapy with&#xD;
               glucocorticoids and at least 2 other immunosuppressive medications being tried for at&#xD;
               least 12 weeks within 24 months of screening.&#xD;
  &#xD;
            -  At least one of: anti-dsDNA, anti-histone, anti-chromatin, and/or anti-Sm antibodies&#xD;
               detectable at screening as assessed by a CLIA-certified laboratory.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active severe lupus nephritis, active severe CNS lupus, and/or neurological symptoms&#xD;
               of SLE including headache, seizure, psychosis, and organic brain syndrome (a patient&#xD;
               with an incidental headache, deemed unrelated to SLE, may re-screen by telephone upon&#xD;
               resolution of the headache);&#xD;
  &#xD;
            -  Major chronic illness that is not well managed at the time of study entry and in the&#xD;
               opinion of the investigator may increase the risk to the patient.&#xD;
  &#xD;
            -  Patient is pregnant or lactating.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Descartes-08</keyword>
    <keyword>CART</keyword>
    <keyword>CAR-T</keyword>
    <keyword>Autoimmune</keyword>
    <keyword>Auto-antibody</keyword>
    <keyword>Auto antibody</keyword>
    <keyword>chimeric antigen receptor</keyword>
    <keyword>T cells</keyword>
    <keyword>Lupus</keyword>
    <keyword>SLE</keyword>
    <keyword>Lupus Erythematosus</keyword>
    <keyword>Systemic Lupus Erythematosus</keyword>
    <keyword>LE</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06038474
  org study id: DC08-SLE-001
  nct id: NCT06038474
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a Phase II study to evaluate the safety, tolerability and manufacturing feasibility
        of Descartes-08 CAR T-cells in patients with Systematic Lupus erythematosus (SLE).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Assess safety and tolerability of Descartes-08 in patients with systemic lupus erythematosus (SLE)
  time frame: Day -59 to Day 50
  description: Results will be descriptive. Safety and tolerability endpoints will include descriptive statistics of AEs and SAEs. Patients must be followed until all AEs have resolved to Grade 2 or less except for lymphopenia and alopecia.
  measure: Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)
  time frame: Day -59 to Month 12
  description: Assessment of Systemic Lupus Erythematosus Disease Activity Index 2000 from baseline administration at various timepoints up to month 12 follow up visit.
  measure: Quantify the clinical activity of Descartes-08 in patients with SLE using Systemic Lupus Erythematosus Responder Index (SRI)
  time frame: Day -59 to Month 12
  description: Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at various timepoints up to month 12 follow up visit.
  measure: Quantify the clinical activity of Descartes-08 in patients with SLE using British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA)
  time frame: Day -59 to Month 12
  description: Assessment of British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) at various timepoints up to month 12 follow up visit.
  measure: Quantify the clinical activity of Descartes-08 in patients with SLE using Physician Global Assessment (PGA)
  time frame: Day -59 to Month 12
  description: Assessment of Physician Global Assessment (PGA) from baseline administration at various timepoints up to month 12 follow up visit.
  arm group label: Descartes-08
  arm group type: Other
  description: Drug: Descartes-08
  Autologous T-cells expressing a chimeric antigen receptor directed to BCMA
  intervention type: Drug
  intervention name: Descartes-08
  description: Autologous T-cells expressing a chimeric antigen receptor directed to BCMA
  arm group label: Descartes-08
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Lupus Erythematosus, Systemic
  sharing ipd: No