<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/NCT04500431</url>
  </required_header>
  <id_info>
    <org_study_id>200802</org_study_id>
    <nct_id>NCT04500431</nct_id>
  </id_info>
  <brief_title>Clinical Study to Evaluate the Safety and Feasibility of spCART-269 Injection in the Treatment of MM</brief_title>
  <official_title>Clinical Study to Evaluate the Safety and Feasibility of Targeting CD269 Chimeric Antigen Receptor Engineered T Cell (spCART-269) Injection in the Treatment of CD269-positive Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Tongji Hospital, Tongji University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Tongji Hospital, Tongji University School of Medicine</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>
      The trial is a single arm, single-center, non-randomized phase I clinical trial which is&#xD;
      designed to evaluate the safety and efficacy of spCART-269 in treatment of relapsed or&#xD;
      refractory multiple myeloma patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study plans to enroll 10 patients to assess the safety and efficacy of spCART-269.&#xD;
      Subjects who meet the eligibility criteria will receive a single dose of spCART-269&#xD;
      injection. The study will include the following sequential phases: Screening, Pre-treatment&#xD;
      (Cell product preparation; Lymphodepleting Chemotherapy), Treatment and follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2022</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>Occurrence of study related adverse events</measure>
    <time_frame>12 weeks</time_frame>
    <description>Incidence and severity of Treatment emergent adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of remission (DOR)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>12 weeks, 6 months, 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>spCART-269</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>spCART-269 administered by intravenous (IV) infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Targeting CD269 chimeric antigen receptor engineered T cells</intervention_name>
    <description>Targeting CD269 chimeric antigen receptor engineered T cells, single infusion intravenously</description>
    <arm_group_label>spCART-269</arm_group_label>
    <other_name>spCART-269</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The patient was diagnosed as active MM according to the diagnostic criteria of the&#xD;
             International Myeloma Working Group (IMWG)&#xD;
&#xD;
          2. The patient meets any of the following:&#xD;
&#xD;
               1. Have received at least 3 treatment options in the past and include alkylating&#xD;
                  agents, proteasome inhibitors and immunomodulators;&#xD;
&#xD;
               2. If the patient has received a regimen containing proteasome inhibitor and&#xD;
                  immunomodulator for at least 2 courses, and the effect is not good (such as&#xD;
                  disease progression within 60 days of treatment)&#xD;
&#xD;
          3. Voluntary participation in clinical research and signing informed consent&#xD;
&#xD;
          4. Age 18-65, regardless of gender&#xD;
&#xD;
          5. Expected survival time is greater than 12 weeks&#xD;
&#xD;
          6. If the patient has received autologous hematopoietic stem cell transplantation in the&#xD;
             past, a 90-day interval is required&#xD;
&#xD;
          7. Normal bone marrow hematopoietic function, blood routine: hemoglobin ≥ 100 g/L;&#xD;
             absolute neutrophil ≥ 1.5×10^9/L; platelet count ≥ 100×10^9/L&#xD;
&#xD;
          8. Liver function: serum alanine aminotransferase (ALT) and aspartate aminotransferase&#xD;
             (AST) ≤ 2.5 (ULN) times the upper limit of normal value (if abnormal liver function is&#xD;
             mainly caused by tumor infiltration, it can be ≤ 5 times the upper limit of normal&#xD;
             value (ULN) )), bilirubin &lt;2.0 mg/dL&#xD;
&#xD;
          9. Renal function: BUN is 9-20 mg/dL, serum creatinine ≤ 1.5 times the upper limit of&#xD;
             normal (ULN), endogenous creatinine clearance rate ≥50 ml/min&#xD;
&#xD;
         10. Serum virus EBV, CMV, HBV, HCV, HIV and syphilis antibodies are negative&#xD;
&#xD;
         11. Heart function: good hemodynamic stability, left ventricular ejection fraction (LVEF)&#xD;
             ≥ 45%&#xD;
&#xD;
         12. ECOG physical status score 0-2&#xD;
&#xD;
         13. Possess apheresis or sufficient venous access for venous blood, and no other&#xD;
             contraindications for leukocyte separation&#xD;
&#xD;
         14. T cells can be successfully expanded in vitro&#xD;
&#xD;
         15. Women of childbearing age who provide negative reports of pregnancy tests with serum&#xD;
             or urine before reinfusion&#xD;
&#xD;
         16. Adults with fertility requirements, regardless of sex, contraception within one year&#xD;
             after treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ECOG score ≥ 3 points&#xD;
&#xD;
          2. Female patients during pregnancy or lactation&#xD;
&#xD;
          3. Pathological examination revealed malignant tumor cells with T cell origin&#xD;
&#xD;
          4. Organ failure: Heart failure grade Ⅲ and Ⅳ; liver reaches Child-Turcotte liver&#xD;
             function grade C; renal failure and uremia; respiratory failure; consciousness&#xD;
             disorder&#xD;
&#xD;
          5. Patients with acute or chronic GVHD after allogeneic hematopoietic transplantation, or&#xD;
             using hormones or immunosuppressants within 30 days&#xD;
&#xD;
          6. Patients with HIV infection or active hepatitis&#xD;
&#xD;
          7. There are other uncontrolled active infections&#xD;
&#xD;
          8. Those who may be allergic to cytokines&#xD;
&#xD;
          9. Those who have used any gene therapy products&#xD;
&#xD;
         10. Those who participated in other clinical studies 4 weeks before enrollment (except&#xD;
             those who did not receive treatment in clinical studies)&#xD;
&#xD;
         11. Patients with systemic autoimmune diseases or immunodeficiency diseases&#xD;
&#xD;
         12. Definite neuropathy or psychosis, including authors of dementia or epilepsy&#xD;
&#xD;
         13. Those with lung or intestinal tumor infiltration&#xD;
&#xD;
         14. Patients that other researchers think are not suitable for enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aibin Liang, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Tongji Hospital, Tongji University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aibin Liang, MD, Ph.D</last_name>
    <phone>0086-021-66111019</phone>
    <email>lab7182@tongji.edu.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ping Li, MD,Ph.D.</last_name>
    <phone>0086-021-66111015</phone>
    <email>lilyforever76@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Shanghai Tongji Hospital, Tongji University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200065</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aibin Liang, MD, Ph.D</last_name>
      <phone>0086-021-66111019</phone>
      <email>lab7182@tongji.edu.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 2, 2020</study_first_submitted>
  <study_first_submitted_qc>August 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>August 2, 2020</last_update_submitted>
  <last_update_submitted_qc>August 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Tongji Hospital, Tongji University School of Medicine</investigator_affiliation>
    <investigator_full_name>Aibin Liang，MD，Ph.D.</investigator_full_name>
    <investigator_title>Vice President of Tongji Hospital</investigator_title>
  </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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data sets generated and analysed during the current study are available from the corresponding author on reasonable request.</ipd_description>
  </patient_data>
  <!-- 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/NCT04500431
org study id: 200802
nct id: NCT04500431
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The trial is a single arm, single-center, non-randomized phase I clinical trial which is
      designed to evaluate the safety and efficacy of spCART-269 in treatment of relapsed or
      refractory multiple myeloma patients.
This study plans to enroll 10 patients to assess the safety and efficacy of spCART-269.
      Subjects who meet the eligibility criteria will receive a single dose of spCART-269
      injection. The study will include the following sequential phases: Screening, Pre-treatment
      (Cell product preparation; Lymphodepleting Chemotherapy), Treatment and follow-up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Occurrence of study related adverse events
time frame: 12 weeks
description: Incidence and severity of Treatment emergent adverse events
measure: Overall response rate (ORR)
time frame: 12 months
measure: Duration of remission (DOR)
time frame: 12 months
measure: Progression free survival (PFS)
time frame: 12 months
measure: Overall survival (OS)
time frame: 12 weeks, 6 months, 12 months
arm group label: spCART-269
arm group type: Experimental
description: spCART-269 administered by intravenous (IV) infusion
intervention type: Biological
intervention name: Targeting CD269 chimeric antigen receptor engineered T cells
description: Targeting CD269 chimeric antigen receptor engineered T cells, single infusion intravenously
arm group label: spCART-269
other name: spCART-269
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Aibin Liang, MD, Ph.D
role: Principal Investigator
affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
last name: Aibin Liang, MD, Ph.D
phone: 0086-021-66111019
email: lab7182@tongji.edu.cn
last name: Ping Li, MD,Ph.D.
phone: 0086-021-66111015
email: lilyforever76@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Tongji Hospital, Tongji University School of Medicine
investigator full name: Aibin Liang，MD，Ph.D.
investigator title: Vice President of Tongji Hospital
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
sharing ipd: Yes
ipd description: The data sets generated and analysed during the current study are available from the corresponding author on reasonable request.