<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/NCT04404595</url>
  </required_header>
  <id_info>
    <org_study_id>CT041-ST-02</org_study_id>
    <nct_id>NCT04404595</nct_id>
  </id_info>
  <brief_title>Claudin18.2 CAR-T (CT041) in Patients With Gastric, Pancreatic Cancer, or Other Specified Digestive Cancers</brief_title>
  <official_title>Open-label, Multicenter, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous Anti-claudin 18.2 Chimeric Antigen Receptor T-cell Therapy in Subjects With Advanced Gastric, Pancreatic, or Other Specified Digestive System Cancers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CARsgen Therapeutics Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CARsgen Therapeutics Co., Ltd.</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>
      A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells&#xD;
      (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other&#xD;
      specified digestive system cancers&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label, multi-center, Phase 1b/2 clinical trial to evaluate the safety and&#xD;
      efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in patients with&#xD;
      advanced gastric, pancreatic or other specified digestive system cancers.&#xD;
&#xD;
      Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. Patients&#xD;
      meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous&#xD;
      mononuclear cells for manufacture of investigational drug product (CT041). Following&#xD;
      manufacture of the drug product, subjects will receive preconditioning prior to CT041&#xD;
      infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 23, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2035</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2025</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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>3+3 dose escalation and expansion</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1b: Incidence of Treatment Related adverse events (AEs)</measure>
    <time_frame>up to 18 mos</time_frame>
    <description>Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 1b: Identification of Maximum Tolerated Dose (MTD) &amp; incidence of Dose-limiting Toxicities (DLTs)</measure>
    <time_frame>day 1 - day 28</time_frame>
    <description>Incidence of dose-limiting toxicities (DLTs)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Objective Response Rate (ORR) per independent central read</measure>
    <time_frame>up to 18 mos</time_frame>
    <description>Rate of subjects experiencing &gt;/= to PR per RECIST 1.1 as determined by IRC assessment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase 1b: Objective Response Rate (ORR) per local assessment</measure>
    <time_frame>up to 18 mos</time_frame>
    <description>Rate of subjects experiencing &gt;/= to PR per RECIST 1.1 as determined by investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b/2: Duration of Response</measure>
    <time_frame>up to 18 mos</time_frame>
    <description>Duration of time from first response to progression of disease as determined by investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b/2: Disease Control Rate</measure>
    <time_frame>up to 18 mos</time_frame>
    <description>Percentage of patients response at least 90 days as determined by investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b/2: Progression free survival</measure>
    <time_frame>up to 18 mos</time_frame>
    <description>duration time after CT041 treatment that patient lives without worsening of disease as determined by investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b/2: Overall survival</measure>
    <time_frame>up to 18 mos</time_frame>
    <description>duration time after CT041 treatment that patient lives as determined by investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b/2: Utilization of Hospital Resources</measure>
    <time_frame>up to 18 mos</time_frame>
    <description>Days of hospitalization during &amp; after CT041 infusion; days of hospitalization in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b/2: Health-related Quality of Life (HRQoL)</measure>
    <time_frame>Baseline - month 18</time_frame>
    <description>Change from baseline in how subjects report the satisfaction with their health as reported on the EORTC QLQ-C30; scoring uses a linear transformation to standardize the raw score such that scores range from 0-100 with a higher score requesting a higher level or function or a higher level of symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2: Incidence of Treatment Related adverse events (AEs)</measure>
    <time_frame>up to 18 mos</time_frame>
    <description>Rate of subjects experiencing &gt;/= to PR per RECIST 1.1 as determined by investigator</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b/2: PK and bio-distribution of CT041</measure>
    <time_frame>Baseline - month 18</time_frame>
    <description>Persistence of CAR transgene copy number</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b/2: CLDN18.2 ICH Assay Performance</measure>
    <time_frame>Baseline - month 18</time_frame>
    <description>Correlation of CLDN18.2 expression level with tumor response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b/2: Anti-CT041 drug antibodies</measure>
    <time_frame>day 0 - month 18</time_frame>
    <description>Number of subjects with anit-CT041 drug antibodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1b/2: Cytokine expression level in blood after CT041 infusion</measure>
    <time_frame>day 0 - month 6</time_frame>
    <description>evaluate cytokine (IL-6 et al) expression levels in patients treated with CT041</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Pancreatic Cancer</condition>
  <arm_group>
    <arm_group_label>anti-claudin18.2 chimeric antigen receptor T-cell therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase 1b will include two parts, dose escalation phase (Cohort A) followed by a dose expansion phase (Cohort B). Phase 2 (Cohort C) will evaluate the chosen dose in patients with advanced gastric cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CT041</intervention_name>
    <description>treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion</description>
    <arm_group_label>anti-claudin18.2 chimeric antigen receptor T-cell therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients are eligible for screening for potential inclusion in the study:&#xD;
&#xD;
          1. Voluntarily signed the ICF;&#xD;
&#xD;
          2. Age ≥ 18 and &lt; 76 years with pathologically/histologically confirmed diagnosis of&#xD;
             adenocarcinoma of the stomach or gastroesophageal junction, referred to collectively&#xD;
             as STAD, or pancreatic adenocarcinoma (PAAD);&#xD;
&#xD;
          3. Must have CLDN18.2-positive tumor expression as determined by the CLDN18.2 IHC assay;&#xD;
&#xD;
          4. Failed or been intolerant of prior lines of systemic therapy;&#xD;
&#xD;
          5. Estimated life expectancy &gt; 4 months;&#xD;
&#xD;
          6. At least 1 measurable lesion per RECIST 1.1;&#xD;
&#xD;
          7. ECOG performance status of 0 or 1;&#xD;
&#xD;
          8. Sufficient venous access for leukapheresis collection and no other contraindications&#xD;
             to leukapheresis;&#xD;
&#xD;
          9. Patients should have reasonable CBC counts, renal and hepatic functions;&#xD;
&#xD;
         10. Women of childbearing age must undergo a serum pregnancy test with negative results&#xD;
             before screening and infusion and be willing to use effective and reliable method of&#xD;
             contraception;&#xD;
&#xD;
         11. Men must be willing to use effective and reliable method of contraception for at least&#xD;
             12-months after T-cell infusion;&#xD;
&#xD;
         12. Sufficient nutritional status.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant or lactating women;&#xD;
&#xD;
          2. HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infusion;&#xD;
&#xD;
          3. Any uncontrolled active infection;&#xD;
&#xD;
          4. AEs from previous treatment that have not recovered;&#xD;
&#xD;
          5. Patients who have clinically significant thyroid dysfunction;&#xD;
&#xD;
          6. Patients allergic to any drugs of the preconditioning regimen, tocilizumab, dimethyl&#xD;
             sulfoxide (DMSO), or CT041 CAR-CLDN18.2 T-cell;&#xD;
&#xD;
          7. Patients who have received prior cellular therapy such as (CAR T, TCR,&#xD;
             tumor-infiltrating lymphocytes) or organ transplantation; Untreated central nervous&#xD;
             system (CNS) metastatic disease, leptomeningeal disease, or cord compression;&#xD;
&#xD;
          8. Untreated CNS, leptomeningeal disease or cord compression&#xD;
&#xD;
          9. Patients with heavy tumor burden such as significant lung disease&#xD;
&#xD;
         10. Unstable/active ulcer or digestive tract bleeding or recent digestive surgery that may&#xD;
             have increased risk of bleeding;&#xD;
&#xD;
         11. Patients who have a history of esophageal or gastric resection with increased risk of&#xD;
             bleeding or perforation;&#xD;
&#xD;
         12. Patients requiring anticoagulant therapy such as warfarin or heparin;&#xD;
&#xD;
         13. Patients requiring long-term antiplatelet therapy;&#xD;
&#xD;
         14. Use of prednisone or other equivalent within 14 days before leukapheresis or&#xD;
             preconditioning;&#xD;
&#xD;
         15. Anticancer treatment within approximately 2 weeks prior to leukapheresis or&#xD;
             approximately preconditioning;&#xD;
&#xD;
         16. Major surgery less than 1 week prior to leukapheresis or 3 weeks prior to&#xD;
             preconditioning;&#xD;
&#xD;
         17. Patients have clinical significant cardiac conditions that researchers believe that&#xD;
             participating in this clinical trial may endanger the health of the patients;&#xD;
&#xD;
         18. Patients have clinical significant pulmonary conditions;&#xD;
&#xD;
         19. Patients known to have active autoimmune diseases;&#xD;
&#xD;
         20. Patients with second malignancies in addition to STAD or PAAD;&#xD;
&#xD;
         21. Patients have significant neurologic disorders;&#xD;
&#xD;
         22. Patients are unable or unwilling to comply with the requirements of clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>76 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harry H Yoon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dae Won Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Moffitt</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hong Ma, MD</last_name>
    <phone>Central Phone</phone>
    <email>clinicalUS@carsgen.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>City of Hope</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Joseph Chao</last_name>
      <email>lbatrow@coh.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90089</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>UCSD</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>G Botta</last_name>
      <email>gbotta@health.ucsd.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UCSF</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marissa Gin</last_name>
      <email>hdfccc.cip@ucsf.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>K Sprenger</last_name>
      <email>kimberly.sprenger@moffitt.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Kansas Cancer Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kasi Anup Kasi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammed Al Hallak</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mayo Cancer Hospital</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A Schimek</last_name>
      <email>schimek.amanda@mayo.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northwell Cancer Institute</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniel King</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Diedre Cohen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Geoffrey Ku</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ohio State University</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anne Noonan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>TX Oncology-Baylor Charles Sammons Cancer Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>A. Rodriguez</last_name>
      <email>Aimee.Rodriguez@BSWHealth.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>M David</last_name>
      <email>mfdavid@mdanderson.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Froedtert Hospital and the Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cancer Center Clinical Trials Office</last_name>
      <phone>414-805-8900</phone>
      <email>CCCTO@mcw.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5GH 2C1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric Chen</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 27, 2020</study_first_posted>
  <last_update_submitted>July 3, 2023</last_update_submitted>
  <last_update_submitted_qc>July 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CAR-T</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04404595
org study id: CT041-ST-02
nct id: NCT04404595
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A Phase 1b/2, open label, multi-center, clinical study of Chimeric Antigen Receptor T Cells
      (CAR-T) targeting claudin18.2 in patients with advanced gastric, pancreatic or other
      specified digestive system cancers
This is an open label, multi-center, Phase 1b/2 clinical trial to evaluate the safety and
      efficacy of autologous claudin18.2 chimeric antigen receptor T-cell therapy in patients with
      advanced gastric, pancreatic or other specified digestive system cancers.

      Following consent, patients must have tumor tissue evaluated by CLDN18.2 IHC assay. Patients
      meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous
      mononuclear cells for manufacture of investigational drug product (CT041). Following
      manufacture of the drug product, subjects will receive preconditioning prior to CT041
      infusion. All subjects will be asked to continue to undergo long-term gene safety follow-up.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: 3+3 dose escalation and expansion
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 1b: Incidence of Treatment Related adverse events (AEs)
time frame: up to 18 mos
description: Incidence of Treatment Related AEs, AEs of special interest and serious adverse events (SAEs)
measure: Phase 1b: Identification of Maximum Tolerated Dose (MTD) & incidence of Dose-limiting Toxicities (DLTs)
time frame: day 1 - day 28
description: Incidence of dose-limiting toxicities (DLTs)
measure: Phase 2: Objective Response Rate (ORR) per independent central read
time frame: up to 18 mos
description: Rate of subjects experiencing >/= to PR per RECIST 1.1 as determined by IRC assessment
measure: Phase 1b: Objective Response Rate (ORR) per local assessment
time frame: up to 18 mos
description: Rate of subjects experiencing >/= to PR per RECIST 1.1 as determined by investigator
measure: Phase 1b/2: Duration of Response
time frame: up to 18 mos
description: Duration of time from first response to progression of disease as determined by investigator
measure: Phase 1b/2: Disease Control Rate
time frame: up to 18 mos
description: Percentage of patients response at least 90 days as determined by investigator
measure: Phase 1b/2: Progression free survival
time frame: up to 18 mos
description: duration time after CT041 treatment that patient lives without worsening of disease as determined by investigator
measure: Phase 1b/2: Overall survival
time frame: up to 18 mos
description: duration time after CT041 treatment that patient lives as determined by investigator
measure: Phase 1b/2: Utilization of Hospital Resources
time frame: up to 18 mos
description: Days of hospitalization during & after CT041 infusion; days of hospitalization in ICU
measure: Phase 1b/2: Health-related Quality of Life (HRQoL)
time frame: Baseline - month 18
description: Change from baseline in how subjects report the satisfaction with their health as reported on the EORTC QLQ-C30; scoring uses a linear transformation to standardize the raw score such that scores range from 0-100 with a higher score requesting a higher level or function or a higher level of symptoms.
measure: Phase 2: Incidence of Treatment Related adverse events (AEs)
time frame: up to 18 mos
description: Rate of subjects experiencing >/= to PR per RECIST 1.1 as determined by investigator
measure: Phase 1b/2: PK and bio-distribution of CT041
time frame: Baseline - month 18
description: Persistence of CAR transgene copy number
measure: Phase 1b/2: CLDN18.2 ICH Assay Performance
time frame: Baseline - month 18
description: Correlation of CLDN18.2 expression level with tumor response
measure: Phase 1b/2: Anti-CT041 drug antibodies
time frame: day 0 - month 18
description: Number of subjects with anit-CT041 drug antibodies
measure: Phase 1b/2: Cytokine expression level in blood after CT041 infusion
time frame: day 0 - month 6
description: evaluate cytokine (IL-6 et al) expression levels in patients treated with CT041
arm group label: anti-claudin18.2 chimeric antigen receptor T-cell therapy
arm group type: Experimental
description: Phase 1b will include two parts, dose escalation phase (Cohort A) followed by a dose expansion phase (Cohort B). Phase 2 (Cohort C) will evaluate the chosen dose in patients with advanced gastric cancer.
intervention type: Biological
intervention name: CT041
description: treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion
arm group label: anti-claudin18.2 chimeric antigen receptor T-cell therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 76 Years
healthy volunteers: No
last name: Harry H Yoon, MD
role: Principal Investigator
affiliation: Mayo
last name: Dae Won Kim, MD
role: Principal Investigator
affiliation: Moffitt
last name: Hong Ma, MD
phone: Central Phone
email: clinicalUS@carsgen.com
facility: 
status: Recruiting
contact: 
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Pancreatic Neoplasms
sharing ipd: No