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/NCT05972720</url>
    </required_header>
    <id_info>
      <org_study_id>CRG-022-101</org_study_id>
      <nct_id>NCT05972720</nct_id>
    </id_info>
    <brief_title>A Phase 2 Study of CRG-022 in Participants With Relapsed/Refractory Large B-cell Lymphoma</brief_title>
    <official_title>An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of CRG-022, a CD22-directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Participants With Relapsed/Refractory Large B-Cell Lymphoma After CD19-directed CAR T-cell Therapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>CARGO Therapeutics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>CARGO Therapeutics</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>
        This is a prospective, open-label, multi-center clinical study designed to evaluate the&#xD;
        safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of&#xD;
        CRG-022, a CD22-directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy for the&#xD;
        treatment of relapsed or refractory large B-cell lymphoma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Primary Objective:&#xD;
  &#xD;
        To evaluate the efficacy of CRG-022 in participants with LBCL&#xD;
  &#xD;
        Secondary Objectives:&#xD;
  &#xD;
        Efficacy-related:&#xD;
  &#xD;
        1. To evaluate the efficacy of CRG-022 in participants with LBCL&#xD;
  &#xD;
        Safety-related:&#xD;
  &#xD;
        To evaluate the safety and tolerability of CRG-022 when administered following conditioning&#xD;
        chemotherapy&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 13, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 13, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>The study will enroll ~ 123 participants in 3 cohorts:&#xD;
  Cohort 1: ~ 81 Participants will be treated with a target dose of 1 x 10^6 CRG-022 cells/kg. Participants in this cohort will have received prior CD19-directed CAR T therapy.&#xD;
  Cohort 2: ~ 5-10 Participants will be treated with nonconforming CRG-022 therapy deemed safe to administer.&#xD;
  Cohort 3:~20 Participants will be treated with a target dose of 1 x 10^6 CRG-022 cells/kg. Participants in this cohort will have received prior bispecific T-cell engaging antibody therapy.&#xD;
  Study Procedures:&#xD;
  PBMC will be obtained by leukapheresis for the manufacturing of CRG-022 at designated Cell Processing Facility. Cryopreserved CRG-022 will then be shipped back to the treating facility&#xD;
  On Day -5, patients will begin conditioning chemotherapy comprising fludarabine and cyclophosphamide on Days -5, -4, and -3&#xD;
  On Day 0, CRG-022 cells will be administered&#xD;
  Patients will be monitored for toxicity, response, and other biologic correlates</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Objective response rate - Blinded independent review</measure>
      <time_frame>3 months, 9 months, and 24 month post-treatment follow-up after CRG-022 infusion</time_frame>
      <description>Percentage of participants with complete or partial response determined by a blinded independent review committee according to 2014 Lugano criteria.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective response rate - Investigator assessment</measure>
      <time_frame>3 months, 9 months, and 24-month post-treatment follow-up after CRG-022 infusion</time_frame>
      <description>Percentage of participants with complete or partial response determined by the investigator according to Lugano criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Complete response rate</measure>
      <time_frame>3 months, 9 months, and 24-month post-treatment follow-up after CRG-022 infusion</time_frame>
      <description>Percentage of participants who achieve a Complete Response determined by independent review committee and investigators assessment according to Lugano criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response</measure>
      <time_frame>3 months, 9 months and 24-month post-treatment follow-up after CRG-022 infusion</time_frame>
      <description>Duration of response (the time from the date of the first occurrence of response to the date of progression, relapse, or death from any cause) determined by independent review committee and investigators according to Lugano criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>3 months, 9 months, and 24-month post-treatment follow-up after CRG-022 infusion</time_frame>
      <description>Progression-free survival (the time from CRG-022 infusion until the first occurrence of disease progression or relapse) determined by independent review committee and investigator assessment according to Lugano criteria.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Survival</measure>
      <time_frame>3 months, 9 months, and 24-month post-treatment follow-up after CRG-022 infusion</time_frame>
      <description>Overall Survival (the period from the date of CRG-022 infusion until the date of death from any cause) documented by the investigators.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence rate of adverse events</measure>
      <time_frame>From Screening up to 15 years at protocol-defined timepoints</time_frame>
      <description>Percentage of participants with treatment-related adverse events is assessed by CTCAEv5.0, CRS, ICANS, and IEC-HS graded by ASTCT criteria.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">123</enrollment>
    <condition>Cancer</condition>
    <condition>Relapsed/Refractory Large B-cell Lymphoma (LBCL)</condition>
    <arm_group>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Relapsed/refractory Large B-cell Lymphoma (Participants in this cohort will have received prior CD19-directed CAR T therapy)&#xD;
  Approximately 81 participants will be treated with a target dose of 1 x 10^6 CRG-022 cells/kg. Participants in this cohort will have received prior CD19-directed CAR T therapy.&#xD;
  Lymphodepletion prior to CRG-022 cell infusion (Day 0) will occur as follows:&#xD;
  Fludarabine 30 mg/m^2 daily by intravenous administration for 3 days (On Days -5, -4, -3)&#xD;
  Cyclophosphamide 500 mg/m^2 daily by intravenous administration for 3 days (on Days -5, -4 and -3)&#xD;
  Autologous CRG-022 cells will be administered intravenously at dose 1 x 10^6 cells/kg on Day 0 after induction chemotherapy regimen.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Relapsed/refractory Large B-cell Lymphoma (Patients in this cohort will receive nonconforming CRG-022 cell product that is deemed safe to administer)&#xD;
  Lymphodepletion prior to CRG-022 cell infusion (Day 0) will occur as follows:&#xD;
  Fludarabine 30 mg/m^2 daily by intravenous administration for 3 days (On Days -5, -4, -3)&#xD;
  Cyclophosphamide 500 mg/m^2 daily by intravenous administration for 3 days (on Days -5, -4 and -3)&#xD;
  Autologous CRG-022 cells will be administered intravenously at dose 0.1 x 10^6 cells/kg on Day 0 after induction chemotherapy regimen (minimum dose).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 3</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Relapsed/refractory Large B-cell Lymphoma (Participants in this cohort will have received prior bispecific T-cell engaging antibody therapy)&#xD;
  Lymphodepletion prior to CRG-022 cell infusion (Day 0) will occur as follows:&#xD;
  Fludarabine 30 mg/m^2 daily by intravenous administration for 3 days (On Days -5, -4, -3)&#xD;
  Cyclophosphamide 500 mg/m^2 daily by intravenous administration for 3 days (on Days -5, -4 and -3)&#xD;
  Autologous CRG-022 cells will be administered intravenously at dose 1 x 10^6 cells/kg on Day 0 after induction chemotherapy regimen.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Fludarabine (30 mg/m^2)</intervention_name>
      <description>Fludarabine 30 mg/m^2 daily by intravenous administration for 3 days (On Days -5, -4, -3)</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cyclophosphamide (500 mg/m^2)</intervention_name>
      <description>Cyclophosphamide 500 mg/m^2 daily by intravenous administration for 3 days (on Days -5, -4 and -3)</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>CRG-022 cells</intervention_name>
      <description>Autologous CRG-022 cells will be administered intravenously on Day 0 after induction chemotherapy regimen.</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_label>Cohort 3</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Must provide signed informed consent&#xD;
  &#xD;
            -  Must be aged ≥18 years&#xD;
  &#xD;
            -  Must have histological confirmation of LBCL&#xD;
  &#xD;
            -  Must have relapsed or refractory disease after the last therapy&#xD;
  &#xD;
            -  For enrollment in cohort 1, patients must have previously received a CD19-directed CAR&#xD;
               T-cell therapy&#xD;
  &#xD;
            -  For enrollment in cohort 3, patients must have received at least 2 prior lines of&#xD;
               therapy including a bispecific T-cell engaging antibody therapy&#xD;
  &#xD;
            -  Must have at least one radiographically measurable lesion&#xD;
  &#xD;
            -  Must have a washout period of at least 2 weeks or five half-lives, whichever is&#xD;
               shorter, since any prior cancer therapy&#xD;
  &#xD;
            -  A tumor tissue sample along with a corresponding local pathology report, must be&#xD;
               available for submission to the Sponsor&#xD;
  &#xD;
            -  Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1&#xD;
  &#xD;
            -  Hematology and organ function:&#xD;
  &#xD;
                 1. Absolute neutrophil count ≥ 1000/μL&#xD;
  &#xD;
                 2. Platelet count ≥ 75,000/μL or ≥ 50,000/μL with known presence of marrow disease&#xD;
  &#xD;
                 3. Absolute lymphocyte count ≥ 100/μL&#xD;
  &#xD;
                 4. Estimated creatinine clearance ≥ 45 mL/minute&#xD;
  &#xD;
                 5. Serum alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the&#xD;
                    upper limit of normal&#xD;
  &#xD;
                 6. Total bilirubin ≤ 1.5 mg/dL&#xD;
  &#xD;
                 7. Cardiac left ventricular ejection fraction (LVEF) ≥45% and no evidence of&#xD;
                    pericardial effusion&#xD;
  &#xD;
                 8. Blood oxygen saturation &gt; 92%&#xD;
  &#xD;
                 9. Serum albumin ≥ 2.5 g/dL&#xD;
  &#xD;
            -  Women of childbearing potential must agree to remain abstinent or use contraceptive&#xD;
               methods&#xD;
  &#xD;
            -  Men must agree to be abstinent (refrain from heterosexual intercourse) or use a condom&#xD;
  &#xD;
            -  Able and willing to comply with the study protocol&#xD;
  &#xD;
            -  Willing and able to remain within 1 hour of the treating center for at least 4 weeks&#xD;
               after infusion&#xD;
  &#xD;
            -  Must be stable or have recovered from nonhematologic toxicities due to prior therapy&#xD;
               to grade ≤ 1&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients who have a history of malignancy other than the lymphoma&#xD;
  &#xD;
            -  Patients with active fungal, bacterial, viral, or other infection that requires&#xD;
               intravenous antimicrobials.&#xD;
  &#xD;
            -  Patients who received prior allogeneic stem cell or solid organ transplant&#xD;
  &#xD;
            -  Patients who received prior allogeneic CAR therapy or anti-CD52 antibody therapy&#xD;
  &#xD;
            -  Patients who received prior bispecific T-cell engaging antibody therapy (e.g.,&#xD;
               glofitamab, epcoritamab) may not be enrolled in cohort 1&#xD;
  &#xD;
            -  Patients with history of central nervous system (CNS) involvement of lymphoma within 1&#xD;
               year prior to enrollment&#xD;
  &#xD;
            -  Patients with ongoing cardiac involvement of lymphoma&#xD;
  &#xD;
            -  History of CD22-directed therapy for lymphoma&#xD;
  &#xD;
            -  History of infection with any of the following: human immunodeficiency virus;&#xD;
               hepatitis B virus or hepatitis C virus&#xD;
  &#xD;
            -  Patients with significant, uncontrolled concomitant disease including the following:&#xD;
  &#xD;
                 1. History of cardiac disease within 12 months prior to enrollment&#xD;
  &#xD;
                 2. Active pulmonary disease&#xD;
  &#xD;
                 3. Clinically significant liver disease&#xD;
  &#xD;
                 4. Clinically significant neurological disease&#xD;
  &#xD;
            -  History of autoimmune disease or requiring systemic immunosuppression and/or systemic&#xD;
               disease modifying agents within the last 2 years&#xD;
  &#xD;
            -  Patients with evidence of moderate to severe forms of primary immunodeficiencies&#xD;
  &#xD;
            -  History of severe, immediate hypersensitivity reaction attributed to aminoglycosides&#xD;
               or any of the agents used in this study&#xD;
  &#xD;
            -  Women of child-bearing potential who are pregnant or breastfeeding&#xD;
  &#xD;
            -  Patients who underwent recent major surgery (within 4 weeks prior to leukapheresis),&#xD;
               other than for diagnosis&#xD;
  &#xD;
            -  Patients with any in-dwelling line or drain and ommaya reservoirs&#xD;
  &#xD;
            -  History of symptomatic deep vein thrombosis or pulmonary embolism requiring&#xD;
               anticoagulation therapy within 6 months prior to enrollment&#xD;
  &#xD;
            -  Patients who received treatment with a live, attenuated vaccine within 6 weeks prior&#xD;
               to initiation of study treatment or who are anticipated to need such a vaccine during&#xD;
               the course of the study&#xD;
  &#xD;
            -  Patients with Richter's transformation of CLL&#xD;
  &#xD;
            -  Patients with T cell/histiocyte-rich large B-cell lymphoma&#xD;
  &#xD;
            -  Patients who require urgent therapy due to mass effects of tumor of impending&#xD;
               oncologic emergency&#xD;
  &#xD;
            -  Patients undergoing concurrent treatment with any other investigational agent&#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_contact>
      <last_name>Alison Sibley</last_name>
      <phone>1-617-645-2087</phone>
      <email>asibley@cargo-tx.com</email>
    </overall_contact>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 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>
    <keyword>Lymphoma</keyword>
    <keyword>CD-22 Expressing Tumor</keyword>
    <keyword>Chimeric Antigen Receptor</keyword>
    <keyword>Adoptive Immunotherapy</keyword>
    <keyword>Lymphoma, B-Cell</keyword>
    <keyword>Lymphoma, Large B-Cell, Diffuse</keyword>
    <keyword>Lymphoma, Primary Mediastinal B-cell</keyword>
    <keyword>Lymphoma, Transformed</keyword>
    <keyword>Lymphoma, Transformed Non-Hodgkin</keyword>
    <keyword>Neoplasms by Histologic Type</keyword>
    <keyword>Lymphoma, Non-Hodgkin</keyword>
    <keyword>Neoplasms</keyword>
    <keyword>Lymphoproliferative Disorders</keyword>
    <keyword>Lymphatic Diseases</keyword>
    <keyword>Immunoproliferative Disorders</keyword>
    <keyword>Immune System Diseases</keyword>
    <keyword>Cyclophosphamide</keyword>
    <keyword>Fludarabine</keyword>
    <keyword>Axicabtagene ciloleucel</keyword>
    <keyword>Lisocabtagene maraleucel</keyword>
    <keyword>Tisagenlecleucel</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lymphoma</mesh_term>
      <mesh_term>Lymphoma, B-Cell</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cyclophosphamide</mesh_term>
      <mesh_term>Fludarabine</mesh_term>
    </intervention_browse>
    <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/NCT05972720
  org study id: CRG-022-101
  nct id: NCT05972720
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a prospective, open-label, multi-center clinical study designed to evaluate the
        safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of
        CRG-022, a CD22-directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy for the
        treatment of relapsed or refractory large B-cell lymphoma.
  Primary Objective:
  
        To evaluate the efficacy of CRG-022 in participants with LBCL
  
        Secondary Objectives:
  
        Efficacy-related:
  
        1. To evaluate the efficacy of CRG-022 in participants with LBCL
  
        Safety-related:
  
        To evaluate the safety and tolerability of CRG-022 when administered following conditioning
        chemotherapy
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: The study will enroll ~ 123 participants in 3 cohorts:
  Cohort 1: ~ 81 Participants will be treated with a target dose of 1 x 10^6 CRG-022 cells/kg. Participants in this cohort will have received prior CD19-directed CAR T therapy.
  Cohort 2: ~ 5-10 Participants will be treated with nonconforming CRG-022 therapy deemed safe to administer.
  Cohort 3:~20 Participants will be treated with a target dose of 1 x 10^6 CRG-022 cells/kg. Participants in this cohort will have received prior bispecific T-cell engaging antibody therapy.
  Study Procedures:
  PBMC will be obtained by leukapheresis for the manufacturing of CRG-022 at designated Cell Processing Facility. Cryopreserved CRG-022 will then be shipped back to the treating facility
  On Day -5, patients will begin conditioning chemotherapy comprising fludarabine and cyclophosphamide on Days -5, -4, and -3
  On Day 0, CRG-022 cells will be administered
  Patients will be monitored for toxicity, response, and other biologic correlates
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate - Blinded independent review
  time frame: 3 months, 9 months, and 24 month post-treatment follow-up after CRG-022 infusion
  description: Percentage of participants with complete or partial response determined by a blinded independent review committee according to 2014 Lugano criteria.
  measure: Objective response rate - Investigator assessment
  time frame: 3 months, 9 months, and 24-month post-treatment follow-up after CRG-022 infusion
  description: Percentage of participants with complete or partial response determined by the investigator according to Lugano criteria
  measure: Complete response rate
  time frame: 3 months, 9 months, and 24-month post-treatment follow-up after CRG-022 infusion
  description: Percentage of participants who achieve a Complete Response determined by independent review committee and investigators assessment according to Lugano criteria
  measure: Duration of response
  time frame: 3 months, 9 months and 24-month post-treatment follow-up after CRG-022 infusion
  description: Duration of response (the time from the date of the first occurrence of response to the date of progression, relapse, or death from any cause) determined by independent review committee and investigators according to Lugano criteria.
  measure: Progression-free survival
  time frame: 3 months, 9 months, and 24-month post-treatment follow-up after CRG-022 infusion
  description: Progression-free survival (the time from CRG-022 infusion until the first occurrence of disease progression or relapse) determined by independent review committee and investigator assessment according to Lugano criteria.
  measure: Overall Survival
  time frame: 3 months, 9 months, and 24-month post-treatment follow-up after CRG-022 infusion
  description: Overall Survival (the period from the date of CRG-022 infusion until the date of death from any cause) documented by the investigators.
  measure: Incidence rate of adverse events
  time frame: From Screening up to 15 years at protocol-defined timepoints
  description: Percentage of participants with treatment-related adverse events is assessed by CTCAEv5.0, CRS, ICANS, and IEC-HS graded by ASTCT criteria.
  arm group label: Cohort 1
  arm group type: Experimental
  description: Relapsed/refractory Large B-cell Lymphoma (Participants in this cohort will have received prior CD19-directed CAR T therapy)
  Approximately 81 participants will be treated with a target dose of 1 x 10^6 CRG-022 cells/kg. Participants in this cohort will have received prior CD19-directed CAR T therapy.
  Lymphodepletion prior to CRG-022 cell infusion (Day 0) will occur as follows:
  Fludarabine 30 mg/m^2 daily by intravenous administration for 3 days (On Days -5, -4, -3)
  Cyclophosphamide 500 mg/m^2 daily by intravenous administration for 3 days (on Days -5, -4 and -3)
  Autologous CRG-022 cells will be administered intravenously at dose 1 x 10^6 cells/kg on Day 0 after induction chemotherapy regimen.
  arm group label: Cohort 2
  arm group type: Experimental
  description: Relapsed/refractory Large B-cell Lymphoma (Patients in this cohort will receive nonconforming CRG-022 cell product that is deemed safe to administer)
  Lymphodepletion prior to CRG-022 cell infusion (Day 0) will occur as follows:
  Fludarabine 30 mg/m^2 daily by intravenous administration for 3 days (On Days -5, -4, -3)
  Cyclophosphamide 500 mg/m^2 daily by intravenous administration for 3 days (on Days -5, -4 and -3)
  Autologous CRG-022 cells will be administered intravenously at dose 0.1 x 10^6 cells/kg on Day 0 after induction chemotherapy regimen (minimum dose).
  arm group label: Cohort 3
  arm group type: Experimental
  description: Relapsed/refractory Large B-cell Lymphoma (Participants in this cohort will have received prior bispecific T-cell engaging antibody therapy)
  Lymphodepletion prior to CRG-022 cell infusion (Day 0) will occur as follows:
  Fludarabine 30 mg/m^2 daily by intravenous administration for 3 days (On Days -5, -4, -3)
  Cyclophosphamide 500 mg/m^2 daily by intravenous administration for 3 days (on Days -5, -4 and -3)
  Autologous CRG-022 cells will be administered intravenously at dose 1 x 10^6 cells/kg on Day 0 after induction chemotherapy regimen.
  intervention type: Drug
  intervention name: Fludarabine (30 mg/m^2)
  description: Fludarabine 30 mg/m^2 daily by intravenous administration for 3 days (On Days -5, -4, -3)
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  intervention type: Drug
  intervention name: Cyclophosphamide (500 mg/m^2)
  description: Cyclophosphamide 500 mg/m^2 daily by intravenous administration for 3 days (on Days -5, -4 and -3)
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  intervention type: Biological
  intervention name: CRG-022 cells
  description: Autologous CRG-022 cells will be administered intravenously on Day 0 after induction chemotherapy regimen.
  arm group label: Cohort 1
  arm group label: Cohort 2
  arm group label: Cohort 3
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Alison Sibley
  phone: 1-617-645-2087
  email: asibley@cargo-tx.com
  responsible party type: Sponsor
  mesh term: Lymphoma
  mesh term: Lymphoma, B-Cell
  mesh term: Cyclophosphamide
  mesh term: Fludarabine
  sharing ipd: No