<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/NCT03758417</url>
  </required_header>
  <id_info>
    <org_study_id>CR108494</org_study_id>
    <secondary_id>68284528MMY2002</secondary_id>
    <nct_id>NCT03758417</nct_id>
  </id_info>
  <brief_title>A Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Chinese Participants With Relapsed or Refractory Multiple Myeloma</brief_title>
  <acronym>CARTIFAN-1</acronym>
  <official_title>A Phase 2, Open-Label Study of LCAR-B38M CAR-T Cells, a Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA in Chinese Subjects With Relapsed or Refractory Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanjing Legend Biotech Co.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Research &amp; Development, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Nanjing Legend Biotech Co.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the efficacy and safety of LCAR-B38M chimeric&#xD;
      antigen receptor T (CAR-T) cells.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 23, 2019</start_date>
  <completion_date type="Anticipated">February 16, 2026</completion_date>
  <primary_completion_date type="Anticipated">February 16, 2026</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>Overall Response Rate (ORR)</measure>
    <time_frame>Minimum 2 years after LCAR-B38M chimeric antigen receptor T (CAR-T) infusion (Day 1)</time_frame>
    <description>The ORR is defined as the percentage of participants who achieve at least a partial response (PR) or better according to international myeloma working group (IMWG) criteria.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Venous blood samples will be collected for measurement of CAR-T positive cellular concentration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transgene Levels of LCAR-B38M CAR-T Cells</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Transgene Levels of LCAR-B38M CAR-T Cells using sensitive assay methods will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic Cytokine Concentrations</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Serum cytokine concentrations such as Interleukin [IL]-6, IL-15, IL-10 will be measured for biomarker assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Anti- LCAR-B38M CAR-T Cell Antibodies</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Number of participants with anti- LCAR-B38M CAR-T cell antibodies will be evaluated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Very Good Partial Response (VGPR) or Better Rate</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>The VGPR or better rate, defined as the percentage of participants achieving VGPR and complete response (CR) (including stringent complete response [sCR]) according to IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than or equal to (&gt;=) 90 percent (%) reduction in serum Mprotein plus urine M-protein less than (&lt;) 100 milligram (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and &lt;5% plasma cells (PCs) in bone marrow. sCR: CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence for 2 to 4 color flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Complete Response (CR)</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Complete response is based on serum M-Protein and bone marrow assessments as per IMWG criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Negative Minimal Residual Disease (MRD)</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Minimal residual disease negative rate is defined as the percentage of participants who achieve MRD negative status by the respective time point. MRD will be assessed by bone marrow 8-colored flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants who Achieve Clinical Benefit</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Clinical Benefit Rate is defined as the percentage of participants who achieve ORR (sCR + CR + VGPR + PR) and minimal response (MR) as per IMWG criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR)</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Duration of response (DOR) will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria or death due to any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response (TTR)</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Time to response (TTR) is defined as the time between date of the initial infusion of LCAR-B38M CAR-T cells and the first efficacy evaluation that the participant has met all criteria for PR or better.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>PFS defined as time from date of initial infusion of LCAR-B38M CAR-T cells to date of first documented disease progression, defined in the IMWG criteria, or death due to any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Mnimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Overall survival (OS) is measured from the date of infusion of the LCAR-B38M CAR-T cells to the date of the participant's death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of CAR-T cell Activation Markers</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Levels of CAR-T cell Activation Markers like CD4+, CD8+, and CD25+ will be assessed. An evaluation of cell populations may be performed by flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of LCAR-B38M CAR-T cell Expansion (proliferation)</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Levels of LCAR-B38M CAR-T cell expansion (proliferation) will be reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Levels of LCAR-B38M CAR-T Persistence</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Levels of LCAR-B38M CAR-T persistence will be evaluated via monitoring CAR-T positive cell counts and CART transgene levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Stringent Complete Response (sCR)</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Stringent Complete Response (sCR) is based on serum M-Protein and bone marrow assessments as per IMWG criteria for complete response(CR) plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry(IHC), or 2 to 4 color flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circulating Soluble B-Cell Maturation Antigen (sBCMA) Levels</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Blood samples will be collected for measurement of sBCMA level.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Reduction in BCMA Expression Cells</measure>
    <time_frame>Minimum 2 years after LCAR-B38M CART infusion (Day 1)</time_frame>
    <description>Percent reduction in BCMA Expression Cells will be measured.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>LCAR-B38M Chimeric Antigen Receptor T Cell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).&#xD;
In addition, participants will enroll in additional cohort to further characterize the safety profile and accumulate efficacy data of LCAR-B38M CAR-T cells.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>LCAR-B38M CAR-T Cell</intervention_name>
    <description>Participants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).</description>
    <arm_group_label>LCAR-B38M Chimeric Antigen Receptor T Cell</arm_group_label>
    <other_name>Ciltacabtagene autoleucel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Documented initial diagnosis of multiple myeloma according to International Myeloma&#xD;
             Working Group (IMWG) diagnostic criteria&#xD;
&#xD;
          -  Measurable disease at Screening&#xD;
&#xD;
          -  Received at least 3 prior lines of treatment for multiple myeloma&#xD;
&#xD;
             a) Undergone at least 1 complete cycle of treatment for each line, unless progressive&#xD;
             disease (PD) was documented by IMWG criteria as the best response to the regimen&#xD;
&#xD;
          -  Received a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD)&#xD;
&#xD;
          -  Participant must have documented evidence of progressive disease based on&#xD;
             investigator's determination of response consistent with IMWG criteria on or within 12&#xD;
             months of their last regimen. Non-responsive disease is defined as either failure to&#xD;
             achieve minimal response or development of progressive disease (PD) while on therapy.&#xD;
             Also, participants with documented evidence of PD disease (as above) within the&#xD;
             previous 6 months and who are refractory or non-responsive to their most recent line&#xD;
             of treatment afterwards are eligible&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status grade of 0 or 1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior treatment with chimeric antigen receptor T (cells) CAR-T therapy directed at any&#xD;
             target&#xD;
&#xD;
          -  Any therapy that is targeted to B-cell maturation antigen (BCMA)&#xD;
&#xD;
          -  The following cardiac conditions: a) New York Heart Association (NYHA) stage III or IV&#xD;
             congestive heart failure b) Myocardial infarction or coronary artery bypass graft&#xD;
             (CABG) 6 months prior to enrollment c) History of clinically significant ventricular&#xD;
             arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to&#xD;
             dehydration d) History of severe non-ischemic cardiomyopathy e) Impaired cardiac&#xD;
             function (left ventricular ejection fraction [LVEF] less than [&lt;]45%) as assessed by&#xD;
             echocardiogram or multiple-gated acquisition (MUGA) scan (performed less than or equal&#xD;
             to (&lt;=) 8 weeks of apheresis)&#xD;
&#xD;
          -  Have received a cumulative dose of corticosteroids equivalent to greater than or equal&#xD;
             to(&gt;=)70 milligram (mg) of prednisone within 7 days prior to apheresis&#xD;
&#xD;
          -  Diagnosed or treated for invasive malignancy other than multiple myeloma, except:&#xD;
&#xD;
               1. Malignancy treated with curative intent and with no known active disease present&#xD;
                  for greater than or equal to (&gt;=) 2 years before enrollment; or&#xD;
&#xD;
               2. Adequately treated non-melanoma skin cancer without evidence of disease&#xD;
&#xD;
          -  Prior antitumor therapy with insufficient washout period&#xD;
&#xD;
          -  Toxicity from previous anticancer therapy must resolve to baseline levels or to Grade&#xD;
             1 or less except for alopecia or peripheral neuropathy&#xD;
&#xD;
          -  Received either of the following:&#xD;
&#xD;
               1. An allogeneic stem cell transplant for multiple myeloma&#xD;
&#xD;
               2. An autologous stem cell transplant less than or equal to (&lt;=) 12 weeks before&#xD;
                  apheresis&#xD;
&#xD;
          -  Known active, or prior history of, central nervous system (CNS) involvement or&#xD;
             exhibits clinical signs of meningeal involvement of multiple myeloma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Janssen Research&amp;Development,LLC Clinical Trail</last_name>
    <role>Study Director</role>
    <affiliation>Janssen Research &amp; Development, LLC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xiaohu Fan</last_name>
    <phone>13851733397</phone>
    <email>frank.fan@legendbiotech.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Qiong Wang</last_name>
    <phone>18051978283</phone>
    <email>wangqiong@legendbiotech.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Peking University Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fujian Medical University Union hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sun Yat -Sen University Cancer Center</name>
      <address>
        <city>Guandong</city>
        <state>Guangzhou</state>
        <zip>510060</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nanjing Drum Tower Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shanghai Changzheng Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiao Tong University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Shanghai Fourth People Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200434</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710004</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Medical School of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>December 27, 2022</last_update_submitted>
  <last_update_submitted_qc>December 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2022</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/NCT03758417
org study id: CR108494
secondary id: 68284528MMY2002
nct id: NCT03758417
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
The purpose of this study is to evaluate the efficacy and safety of LCAR-B38M chimeric
      antigen receptor T (CAR-T) cells.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall Response Rate (ORR)
time frame: Minimum 2 years after LCAR-B38M chimeric antigen receptor T (CAR-T) infusion (Day 1)
description: The ORR is defined as the percentage of participants who achieve at least a partial response (PR) or better according to international myeloma working group (IMWG) criteria.
measure: Number of Participants With Adverse Events
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
measure: Chimeric Antigen Receptor T (CAR-T) Positive Cell Concentration
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Venous blood samples will be collected for measurement of CAR-T positive cellular concentration.
measure: Transgene Levels of LCAR-B38M CAR-T Cells
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Transgene Levels of LCAR-B38M CAR-T Cells using sensitive assay methods will be assessed.
measure: Systemic Cytokine Concentrations
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Serum cytokine concentrations such as Interleukin [IL]-6, IL-15, IL-10 will be measured for biomarker assessment.
measure: Number of Participants With Anti- LCAR-B38M CAR-T Cell Antibodies
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Number of participants with anti- LCAR-B38M CAR-T cell antibodies will be evaluated.
measure: Percentage of Participants with Very Good Partial Response (VGPR) or Better Rate
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: The VGPR or better rate, defined as the percentage of participants achieving VGPR and complete response (CR) (including stringent complete response [sCR]) according to IMWG criteria during or after the study treatment. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than or equal to (>=) 90 percent (%) reduction in serum Mprotein plus urine M-protein less than (<) 100 milligram (mg)/24 hours, CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells (PCs) in bone marrow. sCR: CR plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry (IHC), immunofluorescence for 2 to 4 color flow cytometry.
measure: Percentage of Participants with Complete Response (CR)
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Complete response is based on serum M-Protein and bone marrow assessments as per IMWG criteria.
measure: Percentage of Participants with Negative Minimal Residual Disease (MRD)
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Minimal residual disease negative rate is defined as the percentage of participants who achieve MRD negative status by the respective time point. MRD will be assessed by bone marrow 8-colored flow cytometry.
measure: Percentage of Participants who Achieve Clinical Benefit
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Clinical Benefit Rate is defined as the percentage of participants who achieve ORR (sCR + CR + VGPR + PR) and minimal response (MR) as per IMWG criteria.
measure: Duration of Response (DOR)
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Duration of response (DOR) will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria or death due to any cause, whichever occurs first.
measure: Time to Response (TTR)
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Time to response (TTR) is defined as the time between date of the initial infusion of LCAR-B38M CAR-T cells and the first efficacy evaluation that the participant has met all criteria for PR or better.
measure: Progression-Free Survival (PFS)
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: PFS defined as time from date of initial infusion of LCAR-B38M CAR-T cells to date of first documented disease progression, defined in the IMWG criteria, or death due to any cause, whichever occurs first.
measure: Overall survival (OS)
time frame: Mnimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Overall survival (OS) is measured from the date of infusion of the LCAR-B38M CAR-T cells to the date of the participant's death.
measure: Levels of CAR-T cell Activation Markers
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Levels of CAR-T cell Activation Markers like CD4+, CD8+, and CD25+ will be assessed. An evaluation of cell populations may be performed by flow cytometry.
measure: Levels of LCAR-B38M CAR-T cell Expansion (proliferation)
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Levels of LCAR-B38M CAR-T cell expansion (proliferation) will be reported.
measure: Levels of LCAR-B38M CAR-T Persistence
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Levels of LCAR-B38M CAR-T persistence will be evaluated via monitoring CAR-T positive cell counts and CART transgene levels.
measure: Percentage of Participants with Stringent Complete Response (sCR)
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Stringent Complete Response (sCR) is based on serum M-Protein and bone marrow assessments as per IMWG criteria for complete response(CR) plus normal free light chain (FLC) ratio, and absence of clonal PCs by immunohistochemistry(IHC), or 2 to 4 color flow cytometry.
measure: Circulating Soluble B-Cell Maturation Antigen (sBCMA) Levels
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Blood samples will be collected for measurement of sBCMA level.
measure: Percent Reduction in BCMA Expression Cells
time frame: Minimum 2 years after LCAR-B38M CART infusion (Day 1)
description: Percent reduction in BCMA Expression Cells will be measured.
arm group label: LCAR-B38M Chimeric Antigen Receptor T Cell
arm group type: Experimental
description: Participants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).
In addition, participants will enroll in additional cohort to further characterize the safety profile and accumulate efficacy data of LCAR-B38M CAR-T cells.
intervention type: Biological
intervention name: LCAR-B38M CAR-T Cell
description: Participants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).
arm group label: LCAR-B38M Chimeric Antigen Receptor T Cell
other name: Ciltacabtagene autoleucel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janssen Research&Development,LLC Clinical Trail
role: Study Director
affiliation: Janssen Research & Development, LLC
last name: Xiaohu Fan
phone: 13851733397
email: frank.fan@legendbiotech.com
last name: Qiong Wang
phone: 18051978283
email: wangqiong@legendbiotech.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: China
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell