<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/NCT04416984</url>
  </required_header>
  <id_info>
    <org_study_id>ALLO-501A-201</org_study_id>
    <nct_id>NCT04416984</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA2)</brief_title>
  <acronym>ALPHA2</acronym>
  <official_title>A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Allogene Therapeutics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Allogene 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of&#xD;
      ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion&#xD;
      regimen comprising fludarabine, cyclophosphamide, and ALLO-647&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 21, 2020</start_date>
  <completion_date type="Anticipated">May 2029</completion_date>
  <primary_completion_date type="Anticipated">January 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1: Proportion of subjects experiencing Dose Limiting Toxicities (DLT) at increasing doses of ALLO-501A</measure>
    <time_frame>28 days</time_frame>
    <description>Dose limiting toxicity is defined as protocol-defined ALLO-501A-related adverse events with onset within 28 days following infusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 1: Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501A</measure>
    <time_frame>33 days</time_frame>
    <description>DLT is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2: Overall Response Rate (ORR) assessed per Independent Review Committee (IRC)</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>ORR defined as assessment of CR and PR using Lugano classification criteria 2014</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: Duration of Response (DOR) assessed per IRC (Phase 2 only) and per investigator</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>DOR is defined only for subjects who experience an objective response and is the time from the first objective response to disease progression or death, whichever comes first per (Cheson et al, 2014)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: Overall Response Rate (ORR) assessed per investigator</measure>
    <time_frame>Up to 60 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: Best overall response (CR, PR, SD, PD) assessed per IRC (Phase 2 only) and per investigator</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>CR Complete Response, PR Partial Response, SD Stable Disease, PD Progressive Disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: Progression Free Survival (PFS) assessed per IRC (Phase 2 only) and per investigator</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>PFS, defined as time from the enrollment date to progression, relapse, or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: Time to Response (TTR) assessed per IRC (Phase 2 only) and per investigator</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>TTR, defined as the time from the enrollment date to the first observed response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: Overall Survival (OS)</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>OS, defined as the time from the enrollment date to death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: Depth of lymphodepletion as assessed by lymphocyte count</measure>
    <time_frame>Up to 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: Duration of lymphodepletion as assessed by lymphocyte recovery</measure>
    <time_frame>Up to 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: Serum concentration of ALLO-647 as measured by microgram per microliter for use in a population PK model</measure>
    <time_frame>Up to 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: ALLO-501A expansion assessed by peak blood concentration (Cmax)</measure>
    <time_frame>Up to 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: ALLO-501A expansion assessed by area under the curve (AUC)</measure>
    <time_frame>Up to 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: ALLO-501A persistence assessed by peak blood concentration (Cmax)</measure>
    <time_frame>Up to 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: ALLO-501A persistence assessed by area under the curve (AUC)</measure>
    <time_frame>Up to 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: Pharmacodynamics will be evaluated on host T cell counts</measure>
    <time_frame>Up to 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: The incidence of anti-drug antibodies against ALLO-501A scFv and/or TALEN®</measure>
    <time_frame>Up to 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: The incidence of anti-drug antibodies against ALLO-647</measure>
    <time_frame>Up to 9 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: Adverse Events (AEs) as characterized by preferred term, frequency, severity timing, seriousness, and relationship to ALLO-501A</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>The incidence and severity of Cytokine Release Syndrome (CRS), Graft-Versus-Host Disease (GVHD), infections, cytopenias, and neurotoxicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: AEs as characterized by preferred term, frequency, severity, timing, seriousness, and relationship to ALLO-647</measure>
    <time_frame>Up to 60 months</time_frame>
    <description>The incidence of infusion-related reactions, cytopenias, and infections</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 and 2: The incidence and severity of clinically significant laboratory toxicities</measure>
    <time_frame>Up to 60 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Relapsed/Refractory Large B Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>ALLO-501A, ALLO-647</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>ALLO-501A</intervention_name>
    <description>ALLO-501A is an allogeneic CAR T cell therapy targeting CD19</description>
    <arm_group_label>ALLO-501A, ALLO-647</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>ALLO-647</intervention_name>
    <description>ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen</description>
    <arm_group_label>ALLO-501A, ALLO-647</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludarabine</intervention_name>
    <description>Chemotherapy for lymphodepletion</description>
    <arm_group_label>ALLO-501A, ALLO-647</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cyclophosphamide</intervention_name>
    <description>Chemotherapy for lymphodepletion</description>
    <arm_group_label>ALLO-501A, ALLO-647</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at&#xD;
             last relapse per WHO 2017&#xD;
&#xD;
          -  At least 1 measurable lesion at time of enrollment&#xD;
&#xD;
          -  Relapsed or refractory disease after at least 2 lines of chemotherapy&#xD;
&#xD;
          -  ECOG performance status 0 or 1&#xD;
&#xD;
          -  Absence of donor (product)-specific anti-HLA antibodies (DSA)&#xD;
&#xD;
          -  Adequate hematological, renal, and liver function&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active central nervous system (CNS) involvement by malignancy&#xD;
&#xD;
          -  Current thyroid disorder (including hyperthyroidism), except for subjects with&#xD;
             hypothyroidism controlled on a stable dose of hormone replacement therapy&#xD;
&#xD;
          -  Any other active malignancies that required systemic treatment within 3 years prior to&#xD;
             enrollment&#xD;
&#xD;
          -  Radiation therapy within 2 weeks prior to ALLO-647&#xD;
&#xD;
          -  Prior irradiation to &gt;25% of the bone marrow&#xD;
&#xD;
          -  Hypocellular bone marrow for age by institutional standard as determined from a bone&#xD;
             marrow biopsy performed at time of screening&#xD;
&#xD;
          -  Autologous hematopoietic stem cell transplant (HSCT) within last 6 months (24 weeks)&#xD;
&#xD;
          -  Systemic anti-cancer therapy within 2 weeks prior to receiving ALLO-647&#xD;
&#xD;
          -  Subjects with active systemic bacterial, fungal, or viral infection requiring systemic&#xD;
             treatment (including positive blood cultures within 7 days before starting&#xD;
             lymphodepletion)&#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>Allogene Therapeutics Inc.</last_name>
    <phone>415-604-5696</phone>
    <email>clinicaltrials@allogene.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Banner MD Anderson Cancer Center</name>
      <address>
        <city>Gilbert</city>
        <state>Arizona</state>
        <zip>85234</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natasha Tamula</last_name>
      <phone>480-256-5485</phone>
      <email>natasha.tamula@bannerhealth.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shawn Fleury</last_name>
      <phone>480-342-5622</phone>
      <email>Fleury.Shawn@mayo.edu</email>
    </contact>
  </location>
  <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>Leslie Popplewell, MD</last_name>
      <phone>626-256-4673</phone>
      <phone_ext>82416</phone_ext>
      <email>lpopplew@coh.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annabel Liu</last_name>
      <phone>310-794-7707</phone>
      <email>agliu@mednet.ucla.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Colorado Blood Cancer Institute</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218-1234</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ben Burtness</last_name>
      <phone>303-981-2305</phone>
      <email>ben.burtness@sarahcannon.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jialing Zhang</last_name>
      <phone>203-200-4363</phone>
      <email>jialing.zhang@yale.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lazaros Lekakis, MD</last_name>
      <phone>305-243-5302</phone>
      <email>llekakis@med.miami.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612-9416</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James Rolland</last_name>
      <phone>813-745-4662</phone>
      <email>James.Rolland@moffitt.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northside Hospital - Atlanta</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Caitlin Guzowski</last_name>
      <phone>404-851-8523</phone>
      <email>caitlin.guzowski@northside.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelly Jenkins</last_name>
      <phone>706-721-1206</phone>
      <email>kejenkins@augusta.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel M Ochoa</last_name>
      <phone>708-327-3317</phone>
      <email>raochoa@luc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Norton Cancer Institute</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40207</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dana Haycraft</last_name>
      <phone>502-899-3366</phone>
      <email>dana.haycraft@nortonhealthcare.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Grace Bae</last_name>
      <phone>313-576-8030</phone>
      <email>baeg@karmanos.org</email>
    </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>CAR-T Team</last_name>
      <email>CarT@mskcc.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Neysa Dagostino</last_name>
      <phone>503-215-2608</phone>
      <email>neysa.dagostino@providence.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>John Lister, MD</last_name>
      <email>john.lister@ahn.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Avera Medical</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57117</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Avera Hematology Research</last_name>
      <phone>605-215-7684</phone>
      <email>hematologyresearch@avera.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vanderbilt Ingram Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olalekan Oluwole, MD</last_name>
      <phone>615-936-8422</phone>
      <email>olalekan.oluwole@vumc.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. David's South Austin Medical Center</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78704</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tiffany Cardona</last_name>
      <phone>615-329-7236</phone>
      <email>Tiffany.Cardona@sarahcannon.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75251</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christine Terraciano</last_name>
      <phone>214-370-1942</phone>
      <email>Christine.Terraciano@usoncology.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center - University of Texas</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Swapna Johncy</last_name>
      <phone>832-454-5666</phone>
      <email>sjjohncy@mdanderson.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>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>Roisin McAndrew</last_name>
      <phone>414-805-4557</phone>
      <email>rmcandrew@mcw.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Claudia Piechnik, BSc., CCRP</last_name>
      <phone>604-875-4111</phone>
      <phone_ext>22958</phone_ext>
      <email>claudia.piechnik@bccancer.bc.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CAR T</keyword>
  <keyword>Cell Therapy</keyword>
  <keyword>Allogeneic Cell Therapy</keyword>
  <keyword>Cellular Immuno-therapy</keyword>
  <keyword>AlloCAR T</keyword>
  <keyword>ALLO-501A</keyword>
  <keyword>ALLO-647</keyword>
  <keyword>LBCL</keyword>
  <keyword>Lymphoma</keyword>
  <keyword>Large B-Cell Lymphoma</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>
  <!-- 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/NCT04416984
org study id: ALLO-501A-201
nct id: NCT04416984
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of
      ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion
      regimen comprising fludarabine, cyclophosphamide, and ALLO-647
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 1: Proportion of subjects experiencing Dose Limiting Toxicities (DLT) at increasing doses of ALLO-501A
time frame: 28 days
description: Dose limiting toxicity is defined as protocol-defined ALLO-501A-related adverse events with onset within 28 days following infusion
measure: Phase 1: Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501A
time frame: 33 days
description: DLT is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion
measure: Phase 2: Overall Response Rate (ORR) assessed per Independent Review Committee (IRC)
time frame: Up to 60 months
description: ORR defined as assessment of CR and PR using Lugano classification criteria 2014
measure: Phase 1 and 2: Duration of Response (DOR) assessed per IRC (Phase 2 only) and per investigator
time frame: Up to 60 months
description: DOR is defined only for subjects who experience an objective response and is the time from the first objective response to disease progression or death, whichever comes first per (Cheson et al, 2014)
measure: Phase 1 and 2: Overall Response Rate (ORR) assessed per investigator
time frame: Up to 60 months
measure: Phase 1 and 2: Best overall response (CR, PR, SD, PD) assessed per IRC (Phase 2 only) and per investigator
time frame: Up to 60 months
description: CR Complete Response, PR Partial Response, SD Stable Disease, PD Progressive Disease
measure: Phase 1 and 2: Progression Free Survival (PFS) assessed per IRC (Phase 2 only) and per investigator
time frame: Up to 60 months
description: PFS, defined as time from the enrollment date to progression, relapse, or death
measure: Phase 1 and 2: Time to Response (TTR) assessed per IRC (Phase 2 only) and per investigator
time frame: Up to 60 months
description: TTR, defined as the time from the enrollment date to the first observed response
measure: Phase 1 and 2: Overall Survival (OS)
time frame: Up to 60 months
description: OS, defined as the time from the enrollment date to death
measure: Phase 1 and 2: Depth of lymphodepletion as assessed by lymphocyte count
time frame: Up to 9 months
measure: Phase 1 and 2: Duration of lymphodepletion as assessed by lymphocyte recovery
time frame: Up to 9 months
measure: Phase 1 and 2: Serum concentration of ALLO-647 as measured by microgram per microliter for use in a population PK model
time frame: Up to 9 months
measure: Phase 1 and 2: ALLO-501A expansion assessed by peak blood concentration (Cmax)
time frame: Up to 9 months
measure: Phase 1 and 2: ALLO-501A expansion assessed by area under the curve (AUC)
time frame: Up to 9 months
measure: Phase 1 and 2: ALLO-501A persistence assessed by peak blood concentration (Cmax)
time frame: Up to 9 months
measure: Phase 1 and 2: ALLO-501A persistence assessed by area under the curve (AUC)
time frame: Up to 9 months
measure: Phase 1 and 2: Pharmacodynamics will be evaluated on host T cell counts
time frame: Up to 9 months
measure: Phase 1 and 2: The incidence of anti-drug antibodies against ALLO-501A scFv and/or TALEN®
time frame: Up to 9 months
measure: Phase 1 and 2: The incidence of anti-drug antibodies against ALLO-647
time frame: Up to 9 months
measure: Phase 1 and 2: Adverse Events (AEs) as characterized by preferred term, frequency, severity timing, seriousness, and relationship to ALLO-501A
time frame: Up to 60 months
description: The incidence and severity of Cytokine Release Syndrome (CRS), Graft-Versus-Host Disease (GVHD), infections, cytopenias, and neurotoxicity
measure: Phase 1 and 2: AEs as characterized by preferred term, frequency, severity, timing, seriousness, and relationship to ALLO-647
time frame: Up to 60 months
description: The incidence of infusion-related reactions, cytopenias, and infections
measure: Phase 1 and 2: The incidence and severity of clinically significant laboratory toxicities
time frame: Up to 60 months
arm group label: ALLO-501A, ALLO-647
arm group type: Experimental
intervention type: Genetic
intervention name: ALLO-501A
description: ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
arm group label: ALLO-501A, ALLO-647
intervention type: Biological
intervention name: ALLO-647
description: ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
arm group label: ALLO-501A, ALLO-647
intervention type: Drug
intervention name: Fludarabine
description: Chemotherapy for lymphodepletion
arm group label: ALLO-501A, ALLO-647
intervention type: Drug
intervention name: Cyclophosphamide
description: Chemotherapy for lymphodepletion
arm group label: ALLO-501A, ALLO-647
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Allogene Therapeutics Inc.
phone: 415-604-5696
email: clinicaltrials@allogene.com
facility: 
status: Recruiting
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, B-Cell
mesh term: Cyclophosphamide
mesh term: Fludarabine