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/NCT05963100</url>
    </required_header>
    <id_info>
      <org_study_id>2023010142</org_study_id>
      <nct_id>NCT05963100</nct_id>
    </id_info>
    <brief_title>Clinical Study of TCR-like CAR-T Cell Targeted MSLN in the Treatment of Ovarian Cancer</brief_title>
    <official_title>Clinical Study of TCR-like CAR-T Cell Targeted MSLN in the Treatment of Ovarian Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Zhongda Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongda Hospital</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 goal of this clinical trial is to test TCR-like CAR-T in the Treatment of MSLN positive&#xD;
        Ovarian Cancer. The main question it aims to answer are: the safety and efficacy of TCR-like&#xD;
        CAR-T in the Treatment of MSLN positive Ovarian Cancer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 18, 2023</start_date>
    <completion_date type="Anticipated">May 16, 2026</completion_date>
    <primary_completion_date type="Anticipated">May 16, 2026</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>dose climbing test</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>objective response rate(ORR)</measure>
      <time_frame>up to second year</time_frame>
      <description>The objective response rate evaluation will be based on the researcher's evaluation of imaging, and the efficacy evaluation will refer to the evaluation criteria for solid tumors (RECIST 1.1) The objective response rate evaluation will be based on the researcher's evaluation of imaging, and the efficacy evaluation will refer to the evaluation criteria for solid tumors(RECIST 1.1)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>progression-free survival(PFS)</measure>
      <time_frame>up to second year</time_frame>
      <description>Progressive free survival is the time from receiving investigational drug treatment to the onset of the first PD or death from any cause in the absence of documented PD</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall survival,OS</measure>
      <time_frame>up to second year</time_frame>
      <description>The total survival period is the time between receiving investigational drug treatment and subject death due to various reasons</description>
    </primary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Safety and Efficacy of TCR-like CAR-T</condition>
    <arm_group>
      <arm_group_label>Experimental 1*10^6/kg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental 1*10^7/kg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental 3*10^6/kg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental 2*10^7/kg</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>TCR-like CAR-T</intervention_name>
      <description>intravenous drip of TCR-like CAR-T with indicated doses</description>
      <arm_group_label>Experimental 1*10^6/kg</arm_group_label>
      <arm_group_label>Experimental 1*10^7/kg</arm_group_label>
      <arm_group_label>Experimental 2*10^7/kg</arm_group_label>
      <arm_group_label>Experimental 3*10^6/kg</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1: Histologically confirmed diagnosis of advanced ovarian cancer, with a positive rate&#xD;
               of IHC mesothelin in tumor tissue ≥ 26% [Participants need to undergo fresh tumor&#xD;
               tissue biopsy for biomarker analysis]. If biopsy is not possible, it is necessary to&#xD;
               provide archived tumor tissue (at least 8 unstained FFPE sections) within 18 months.&#xD;
               If there have been multiple tumor tissue collections in the past, the newly collected&#xD;
               samples will be prioritized 2: Non resectable advanced ovarian cancer that has failed&#xD;
               standard treatment (has previously received at least one platinum containing systemic&#xD;
               chemotherapy regimen) or lacks effective treatment methods 3: At least 1 measurable&#xD;
               lesion (according to RECIST 1.1 standard) 4: ECOG score 0-1 and estimated survival&#xD;
               greater than 3 months 5: The laboratory test results should at least meet the&#xD;
               following indicators: Lambda Left ventricular Ejection fraction ≥ 45%; Creatinine&#xD;
               clearance rate ≥ 50mL/min; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Absolute&#xD;
               lymphocyte count (ALC) ≥ 0.7 × 109/L; Platelet count (PLT) ≥ 100 × 109/L; Hemoglobin ≥&#xD;
               90g/L; Blood oxygen saturation&gt;91%; Total bilirubin ≤ 2 × ULN (upper limit of normal&#xD;
               value): alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ×&#xD;
               ULN; Researchers have determined that ALT and AST abnormalities caused by diseases&#xD;
               (such as liver metastasis or bile duct obstruction) or Gilbert syndrome can be relaxed&#xD;
               to ≤ 5 × ULN; 6: The researcher determines that the subject needs to recover from all&#xD;
               toxicity related to the previous treatment to an acceptable baseline state, or the&#xD;
               relevant toxicity needs to return to normal or level 1 of the NCI CTCAE 5.0 scoring&#xD;
               standard; Excluding toxicity that the researcher determines will not increase the&#xD;
               safety risk of subsequent study drug reinfusion, such as hair loss, vitiligo, etc; 7:&#xD;
               Can understand this experiment and have signed an informed consent form. 8: Venous&#xD;
               access with venous or single blood collection&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1: Other malignant tumors other than ovarian cancer in the first five years of&#xD;
               screening, in addition to fully treated cervical Carcinoma in situ, basal cell or&#xD;
               squamous cell skin cancer, local prostate cancer after radical surgery, and Ductal&#xD;
               carcinoma in situ after radical surgery; 2: Hepatitis B B surface antigen (HBsAg) or&#xD;
               hepatitis B B core antibody (HBcAb) is positive, and the detection result of hepatitis&#xD;
               B virus (HBV) DNA titer in peripheral blood is higher than 50IU/ml or the lower limit&#xD;
               of the quantitative detection range of the research center; Hepatitis C virus (HCV)&#xD;
               antibody is positive and the peripheral blood HCV RNA detection result is higher than&#xD;
               the lower limit of the quantitative detection range of the research center; People who&#xD;
               are positive for human immunodeficiency virus (HIV) antibodies; Those who have tested&#xD;
               positive for syphilis 3: Patients with ovarian cancer metastasis to the central&#xD;
               nervous system and/or other unstable Central nervous system disease (bleeding, active&#xD;
               infarction, infection, etc.) 4: Received attenuated live vaccine within 4 weeks before&#xD;
               cell transfusion 5: It is known that any ingredient used in the treatment of this&#xD;
               study may cause allergic reactions 6: Hypertension with poor drug control (systolic&#xD;
               pressure&gt;160mmHg and/or diastolic pressure&gt;90mmHg) or cardio cerebral Vascular disease&#xD;
               with clinical significance (such as activity), such as cerebrovascular accident&#xD;
               (within 6 months before signing the master informed consent), myocardial infarction&#xD;
               (within 6 months before signing the master informed consent), unstable angina&#xD;
               pectoris, congestive heart failure classified as Grade II or above by New York Heart&#xD;
               Association (NYHA), Severe arrhythmia cannot be controlled with medication or has&#xD;
               potential impact on research and treatment; The electrocardiogram shows clinically&#xD;
               significant abnormalities or an average QTcB of ≥ 450ms after 3 consecutive attempts&#xD;
               (with an interval of at least 5 minutes) 7: Concomitant with other serious organic or&#xD;
               mental illnesses 8: Suffering from systemic active infections that require treatment&#xD;
               9: ※ Suffering from autoimmune diseases: the history of Autoimmune disease determined&#xD;
               by the researcher to be unsuitable for this study, such as systemic lupus&#xD;
               erythematosus, vasculitis, and invasive lung diseases, should be excluded (except for&#xD;
               Vitiligo subjects) 10: Systematically available pine steroids (local use allowed),&#xD;
               Hydroxycarbamide and immunomodulators (such as: α or γ Interferon, GM-CSF, mTOR&#xD;
               inhibitor, cyclosporin, Thymosin, etc.) 11: Chemotherapy was received 2 weeks before&#xD;
               screening, immunotherapy was received within 4 weeks, radiation therapy was received&#xD;
               12 weeks before screening, or other anti-tumor treatment drugs had a washout period of&#xD;
               less than 5 half-lives 12: ※ Pregnant or lactating women, and female subjects who plan&#xD;
               to conceive within 1 year after cell transfusion 13: Subjects with any coexisting&#xD;
               medical conditions or diseases that the researcher determines may affect the conduct&#xD;
               of this experiment 14: Patients who have received other cell gene therapy products&#xD;
               within 6 months prior to cell reinfusion and are considered unsuitable for inclusion&#xD;
               by researchers 15: The researcher determines that the patient is unable to complete&#xD;
               all visits or procedures required by the research protocol (including the follow-up&#xD;
               period), or has insufficient compliance to participate in this study; Or patients&#xD;
               deemed unsuitable for inclusion by researchers 16: ※ Items included in the selection&#xD;
               and exclusion criteria for the pre screening period audit&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Yang Shen, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Zhongda Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yang Shen, PhD</last_name>
      <phone>+86-025-83262600</phone>
      <email>shenyang@seu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Zhongda hospital</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>210009</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yang Shen</last_name>
        <phone>+86-025-83262600</phone>
        <email>shenyang@seu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Zhongda Hospital</investigator_affiliation>
      <investigator_full_name>Yang Shen</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <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/NCT05963100
  org study id: 2023010142
  nct id: NCT05963100
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test TCR-like CAR-T in the Treatment of MSLN positive
        Ovarian Cancer. The main question it aims to answer are: the safety and efficacy of TCR-like
        CAR-T in the Treatment of MSLN positive Ovarian Cancer.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  intervention model description: dose climbing test
  primary purpose: Treatment
  masking: None (Open Label)
  measure: objective response rate(ORR)
  time frame: up to second year
  description: The objective response rate evaluation will be based on the researcher's evaluation of imaging, and the efficacy evaluation will refer to the evaluation criteria for solid tumors (RECIST 1.1) The objective response rate evaluation will be based on the researcher's evaluation of imaging, and the efficacy evaluation will refer to the evaluation criteria for solid tumors(RECIST 1.1)
  measure: progression-free survival(PFS)
  time frame: up to second year
  description: Progressive free survival is the time from receiving investigational drug treatment to the onset of the first PD or death from any cause in the absence of documented PD
  measure: Overall survival,OS
  time frame: up to second year
  description: The total survival period is the time between receiving investigational drug treatment and subject death due to various reasons
  arm group label: Experimental 1*10^6/kg
  arm group type: Experimental
  arm group label: Experimental 1*10^7/kg
  arm group type: Experimental
  arm group label: Experimental 3*10^6/kg
  arm group type: Experimental
  arm group label: Experimental 2*10^7/kg
  arm group type: Experimental
  intervention type: Biological
  intervention name: TCR-like CAR-T
  description: intravenous drip of TCR-like CAR-T with indicated doses
  arm group label: Experimental 1*10^6/kg
  arm group label: Experimental 1*10^7/kg
  arm group label: Experimental 2*10^7/kg
  arm group label: Experimental 3*10^6/kg
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Yang Shen, PhD
  role: Study Chair
  affiliation: Zhongda Hospital
  last name: Yang Shen, PhD
  phone: +86-025-83262600
  email: shenyang@seu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Zhongda Hospital
  investigator full name: Yang Shen
  investigator title: Professor
  sharing ipd: No