<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/NCT04502446</url>
  </required_header>
  <id_info>
    <org_study_id>CRSP-ONC-004</org_study_id>
    <nct_id>NCT04502446</nct_id>
  </id_info>
  <brief_title>A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory T or B Cell Malignancies (COBALT-LYM)</brief_title>
  <official_title>A Phase 1, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX130) in Subjects With Relapsed or Refractory T or B Cell Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CRISPR Therapeutics AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CRISPR 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 single-arm, open-label, multicenter, Phase 1 study evaluating the safety and&#xD;
      efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study may enroll approximately 45 subjects in total.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 31, 2020</start_date>
  <completion_date type="Anticipated">May 2027</completion_date>
  <primary_completion_date type="Anticipated">March 2027</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Part A (dose escalation)</measure>
    <time_frame>From CTX130 infusion up to 28 days post-infusion</time_frame>
    <description>Incidence of adverse events</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Part B (cohort expansion)</measure>
    <time_frame>From CTX130 infusion up to 60 months post-infusion]</time_frame>
    <description>Objective response rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>From date of CTX130 until date of death due to any cause, assessed up to 60 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>T Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>CTX130</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Administered by IV infusion following lymphodepleting chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>CTX130</intervention_name>
    <description>CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.</description>
    <arm_group_label>CTX130</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (abbreviated):&#xD;
&#xD;
          1. Age ≥18 years.&#xD;
&#xD;
          2. Confirmed diagnosis of a T cell malignancy or Diffuse Large B-Cell Lymphoma (DLBCL).&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.&#xD;
&#xD;
          4. Adequate renal, liver, cardiac, and pulmonary organ function.&#xD;
&#xD;
          5. Female subjects of childbearing potential and male subjects must agree to use&#xD;
             acceptable method(s) of contraception from enrollment through at least 12 months after&#xD;
             CTX130 infusion.&#xD;
&#xD;
        Exclusion Criteria (abbreviated):&#xD;
&#xD;
          1. Prior allogeneic stem cell transplant (SCT).&#xD;
&#xD;
          2. Prior treatment with any anti-CD70 targeting agents.&#xD;
&#xD;
          3. History of certain central nervous system (CNS), cardiac or pulmonary conditions.&#xD;
&#xD;
          4. Active HIV, hepatitis B virus or hepatitis C virus infection.&#xD;
&#xD;
          5. Previous or concurrent malignancy, except treated with curative approach not requiring&#xD;
             systemic therapy and in remission for &gt;12 months, or any other localized malignancy&#xD;
             with low risk of developing into metastatic disease.&#xD;
&#xD;
          6. Primary immunodeficiency disorder or active autoimmune disease requiring steroids&#xD;
             and/or other immunosuppressive therapy.&#xD;
&#xD;
          7. Prior solid organ transplantation.&#xD;
&#xD;
          8. Pregnant or breastfeeding females.&#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_official>
    <last_name>Alissa Keegan, PhD</last_name>
    <role>Study Director</role>
    <affiliation>CRISPR Therapeutics</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Clinical Trials</last_name>
    <phone>+1 (877) 214-4634</phone>
    <email>MedicalAffairs@crisprtx.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Research Site 2</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Research Site 5</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Research Site 10</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Research Site 4</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33124</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Research Site 8</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Research Site 9</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Research Site 1</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Research Site 6</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Research Site 3</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2050</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Research Site 7</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CAR T</keyword>
  <keyword>Allogeneic</keyword>
  <keyword>Lymphoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma, T-Cell</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/NCT04502446
org study id: CRSP-ONC-004
nct id: NCT04502446
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and
      efficacy of CTX130 in subjects with relapsed or refractory T or B cell malignancies.
The study may enroll approximately 45 subjects in total.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Part A (dose escalation)
time frame: From CTX130 infusion up to 28 days post-infusion
description: Incidence of adverse events
measure: Part B (cohort expansion)
time frame: From CTX130 infusion up to 60 months post-infusion]
description: Objective response rate
measure: Progression Free Survival
time frame: From date of CTX130 infusion until date of disease progression or death due to any cause, assessed up to 60 months
measure: Overall Survival
time frame: From date of CTX130 until date of death due to any cause, assessed up to 60 months
arm group label: CTX130
arm group type: Experimental
description: Administered by IV infusion following lymphodepleting chemotherapy.
intervention type: Biological
intervention name: CTX130
description: CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.
arm group label: CTX130
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alissa Keegan, PhD
role: Study Director
affiliation: CRISPR Therapeutics
last name: Clinical Trials
phone: +1 (877) 214-4634
email: MedicalAffairs@crisprtx.com
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Australia
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Lymphoma, T-Cell
sharing ipd: No