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/NCT05971589</url>
    </required_header>
    <id_info>
      <org_study_id>LM103-003</org_study_id>
      <nct_id>NCT05971589</nct_id>
    </id_info>
    <brief_title>A Clinical Study on LM103 Injection for the Treatment of Advanced Solid Tumors</brief_title>
    <official_title>An Exploratory Clinical Study Evaluating the Safety, Tolerance, Immune Response, and Initial Efficacy of Autologous Tumor Infiltrating Lymphocytes (TILs) LM103 Injection in Patients With Advanced Solid Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Suzhou BlueHorse Therapeutics Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Suzhou BlueHorse Therapeutics Co., Ltd.</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>
        This study is an open exploratory clinical study to evaluate the safety, tolerance, immune&#xD;
        response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in&#xD;
        advanced solid tumor patients. The research treatment includes fludarabine and&#xD;
        cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and&#xD;
        Interleukin-2 therapy.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2026</completion_date>
    <primary_completion_date type="Anticipated">April 2026</primary_completion_date>
    <phase>Early 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>Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE)</measure>
      <time_frame>through study completion, an average of 1 year estimate</time_frame>
      <description>Incidence and severity of AE, SAE and irAE; Abnormal changes in laboratory and other tests with clinical significance.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>through study completion, an average of 1 year estimate</time_frame>
      <description>The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR)</measure>
      <time_frame>through study completion, an average of 1 year estimate</time_frame>
      <description>Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR)</measure>
      <time_frame>through study completion, an average of 1 year estimate</time_frame>
      <description>Disease control rate (DCR) was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease as defined by RECIST version 1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to response (TTR)</measure>
      <time_frame>through study completion, an average of 1 year estimate</time_frame>
      <description>Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR or PR.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to disease progression (TTP)</measure>
      <time_frame>through study completion, an average of 1 year estimate</time_frame>
      <description>Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to the solid tumor.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival (PFS)</measure>
      <time_frame>through study completion, an average of 1 year estimate</time_frame>
      <description>Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST version 1.1) or death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>through study completion, an average of 1 year estimate</time_frame>
      <description>OS was defined as the time from first dose to date of death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peripheral blood TILs cell survival</measure>
      <time_frame>through study completion, an average of 1 year estimate</time_frame>
      <description>Detection using flow cytometry</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">5</enrollment>
    <condition>Solid Tumor</condition>
    <arm_group>
      <arm_group_label>Intravenous of LM103</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>≥5×10^9 cells (LM103) will be infused i.v. to patients after non-myeloablative lymphodepletion treatment with Cyclophosphamide for Injection and Fludarabine Phosphate for Injection.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>LM103</intervention_name>
      <description>Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion.</description>
      <arm_group_label>Intravenous of LM103</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The expected survival time is not less than 6 months.&#xD;
  &#xD;
            2. Clinical performance status of Eastern Cooperative Oncology Group (ECOG) 0-1.&#xD;
  &#xD;
            3. Patients with advanced solid tumors confirmed by histology or cytology: advanced&#xD;
               Melanoma, head and neck squamous cell cancer, soft tissue sarcoma and other solid&#xD;
               tumors that have failed standard treatment regimens, cannot tolerate standard&#xD;
               treatment, refuse or do not have standard treatment regimens available.&#xD;
  &#xD;
            4. The patient has lesions that can be used for surgical resection (&gt;1.5 cm^3) or biopsy&#xD;
               puncture (no less than 6 lesions) for TILs collection.&#xD;
  &#xD;
            5. At least one measurable lesion as the target lesion after collecting tumor tissue from&#xD;
               the patient (RECIST v1.1 criteria).&#xD;
  &#xD;
            6. Laboratory tests results during the screening period indicate that the subjects have&#xD;
               sufficient organ function.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Have a medical history of other malignant tumors other than the disease under study in&#xD;
               the past 5 years, except for malignant tumors that can be expected to recover after&#xD;
               treatment (including but not limited to thyroid cancer, cervical Carcinoma in situ,&#xD;
               basal or squamous cell skin cancer or Ductal carcinoma in situ of the breast treated&#xD;
               by radical surgery).&#xD;
  &#xD;
            2. LM103 received systematic Sex therapy of antineoplastic drugs (including chemotherapy,&#xD;
               small molecule targeted drug therapy, Hormone replacement therapy, etc.), or local&#xD;
               antineoplastic therapy (such as radiotherapy, palliative radiotherapy for bone&#xD;
               metastases&gt;2 weeks before the start of the study and intracranial stereotactic&#xD;
               radiotherapy or resection of a single brain metastasis&gt;3 weeks before the start of the&#xD;
               study were acceptable) within 4 weeks before LM103 infusion; Or received clinical&#xD;
               investigational drugs or equipment treatment.&#xD;
  &#xD;
            3. Adverse reactions caused by previous treatment have not recovered to CTCAE (version&#xD;
               5.0) level 1 or below (excluding hair loss and neurotoxicity, which have been&#xD;
               determined by the researchers to be irreparable and level 2 hypothyroidism for a long&#xD;
               time).&#xD;
  &#xD;
            4. Previously received allogeneic hematopoietic stem cell transplantation or solid organ&#xD;
               transplantation.&#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_contact>
      <last_name>Jilong yang</last_name>
      <phone>+86 22-23340123</phone>
      <phone_ext>1081</phone_ext>
      <email>yangjilong@tjmuch.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 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>Neoplasms</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/NCT05971589
  org study id: LM103-003
  nct id: NCT05971589
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is an open exploratory clinical study to evaluate the safety, tolerance, immune
        response, and initial efficacy of autologous tumor infiltrating lymphocyte LM103 injection in
        advanced solid tumor patients. The research treatment includes fludarabine and
        cyclophosphamide, autologous tumor infiltrating lymphocytes (TILs) infusion, and
        Interleukin-2 therapy.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Adverse events (AE), Serious adverse event (SAE) and immune related adverse events (irAE)
  time frame: through study completion, an average of 1 year estimate
  description: Incidence and severity of AE, SAE and irAE; Abnormal changes in laboratory and other tests with clinical significance.
  measure: Objective response rate (ORR)
  time frame: through study completion, an average of 1 year estimate
  description: The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigator assessment based on RECIST version 1.1.
  measure: Duration of response (DOR)
  time frame: through study completion, an average of 1 year estimate
  description: Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause.
  measure: Disease control rate (DCR)
  time frame: through study completion, an average of 1 year estimate
  description: Disease control rate (DCR) was defined as the percentage of participants with a best overall response of complete response, partial response or stable disease as defined by RECIST version 1.1.
  measure: Time to response (TTR)
  time frame: through study completion, an average of 1 year estimate
  description: Time to response (TTR) is defined as the time from randomization until the first documented evidence of CR or PR.
  measure: Time to disease progression (TTP)
  time frame: through study completion, an average of 1 year estimate
  description: Time to progression (TTP) is defined as the interval between the date of randomization and the earliest date of progression of disease (PD) or death due to the solid tumor.
  measure: Progression free survival (PFS)
  time frame: through study completion, an average of 1 year estimate
  description: Progression-free survival (PFS) was defined as the time from the date of enrollment to the earlier of the dates of the first objective documentation of disease progression (as per RECIST version 1.1) or death due to any cause.
  measure: Overall survival (OS)
  time frame: through study completion, an average of 1 year estimate
  description: OS was defined as the time from first dose to date of death from any cause.
  measure: Peripheral blood TILs cell survival
  time frame: through study completion, an average of 1 year estimate
  description: Detection using flow cytometry
  arm group label: Intravenous of LM103
  arm group type: Experimental
  description: ≥5×10^9 cells (LM103) will be infused i.v. to patients after non-myeloablative lymphodepletion treatment with Cyclophosphamide for Injection and Fludarabine Phosphate for Injection.
  intervention type: Biological
  intervention name: LM103
  description: Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion.
  arm group label: Intravenous of LM103
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jilong yang
  phone: +86 22-23340123
  phone ext: 1081
  email: yangjilong@tjmuch.com
  responsible party type: Sponsor
  mesh term: Neoplasms