<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/NCT04457830</url>
  </required_header>
  <id_info>
    <org_study_id>NTP-F520-002</org_study_id>
    <nct_id>NCT04457830</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety of F520 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma (PTCL).</brief_title>
  <official_title>A Phase 2, Open-label, Single-arm, Multicenter Study of the Efficacy and Safety of F520 in Relapsed/Refractory Peripheral T Cell Lymphoma (PTCL).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shandong New Time Pharmaceutical Co., LTD</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shandong New Time Pharmaceutical Co., LTD</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is a multi-center, prospective, open-label, two-stage optimized design, single-arm, phase&#xD;
      II clinical study to evaluate the efficacy and safety of F520 for the treatment of relapsed&#xD;
      and refractory peripheral T cell lymphoma (PTCL), and to evaluate the immunogenicity of F520.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2020</start_date>
  <completion_date type="Anticipated">January 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2022</primary_completion_date>
  <phase>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>F520</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>Approximately 24 months</time_frame>
    <description>To evaluate the efficacy of F520 as defined by objective response rate (evaluated by IRC) in patients with relapsed or refractory PTCL.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR)</measure>
    <time_frame>Approximately 24 months</time_frame>
    <description>To evaluate the efficacy of F520 as defined by objective response rate (evaluated by investigator) in patients with relapsed or refractory PTCL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Completed response rate (CRR)</measure>
    <time_frame>Approximately 24 months</time_frame>
    <description>To evaluate the efficacy of F520 as defined by completed response rate (evaluated by investigator/IRC) in patients with relapsed or refractory PTCL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>Approximately 24 months</time_frame>
    <description>To evaluate the duration of response (DOR) of F520 in patients with relapsed or refractory PTCL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>Approximately 24 months</time_frame>
    <description>To evaluate the duration from the first administration to death because of any reason in patients with relapsed or refractory PTCL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>Approximately 24 months</time_frame>
    <description>To evaluate the efficacy of F520 as defined by progression-free survival, in patients with relapsed or refractory PTCL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>Approximately 24 months</time_frame>
    <description>To evaluate the efficacy of F520 as defined by disease control rate, in patients with relapsed or refractory PTCL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response (TTR)</measure>
    <time_frame>Approximately 24 months</time_frame>
    <description>To evaluate the efficacy of F520 as defined by time to response in patients with relapsed or refractory PTCL.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">105</enrollment>
  <condition>Peripheral T Cell Lymphoma</condition>
  <arm_group>
    <arm_group_label>Single arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>F520</intervention_name>
    <description>3mg/kg every 3 weeks</description>
    <arm_group_label>Single arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18 years or older, male or female;&#xD;
&#xD;
          2. Histologically confirmed relapsed or refractory PTCL patients who had received&#xD;
             systemic treatment at least once but had failed to; Relapsed / refractory is defined&#xD;
             as follows:&#xD;
&#xD;
             Relapsed: patients who have new lesions at the primary site or other sites after&#xD;
             reaching CR in the previous treatment; Refractory: patients who fail to reach PR in 2&#xD;
             cycles or CR in 4 cycles after first-line or above systemic treatment; if the best&#xD;
             effect or end cause is PD, the number of cycles is not required;&#xD;
&#xD;
          3. ECOG score of 0-2;&#xD;
&#xD;
          4. Life expectancy≥3 months;&#xD;
&#xD;
          5. Agree to provide archived tumor tissue samples or fresh tissue samples, including&#xD;
             enough samples to complete PD-L1 test;&#xD;
&#xD;
          6. Computed tomography (ct) scans should show the presence of at least one of two&#xD;
             vertical orientations; The tumor lesions that could be measured were defined, with the&#xD;
             longest diameter of intranode lesion &gt; 1.5cm, the shortest diameter of intranode&#xD;
             lesion &gt; 1.0cm and the longest diameter of extranode lesion &gt; 1.0cm;&#xD;
&#xD;
          7. The functions of important organs meet the following requirements (drugs with any&#xD;
             blood component and cell growth factor are not allowed to be used within 14 days&#xD;
             before the first administration):&#xD;
&#xD;
             routine blood tests: hemoglobin ≥ 90 g/L, neutrophil ≥ 1.5 ×109/L, platelet ≥&#xD;
             75×109/L; Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN),&#xD;
             aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the&#xD;
             upper limit of normal (ULN); If there is liver metastasis, TBIL ≤ 3 × ULN, ALT and AST&#xD;
             ≤ 5 × ULN; Serum creatinine ≤ 1.5×ULN; Thyroid function indicators:&#xD;
             thyroid-stimulating hormone (TSH) are within the normal range or thyroid-stimulating&#xD;
             hormone (TSH) are not within the normal range and free thyroxine (FT3/FT4) are within&#xD;
             the normal range;&#xD;
&#xD;
          8. Sign the written informed consent, and be able to follow the visit and related&#xD;
             procedures specified in the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosed as vascular immunoblastic t-cell lymphoma (AITL) or adult t-cell&#xD;
             lymphoma/leukemia(ATLL);&#xD;
&#xD;
          2. Patients with active central nervous system (CNS) infiltration, including invasion of&#xD;
             brain parenchyma, meninges or compression of spinal cord;&#xD;
&#xD;
          3. Diagnosed as cutaneous extranodal nasal type T-cell lymphoma;&#xD;
&#xD;
          4. Immunohistochemistry confirmed PD-1 positive;&#xD;
&#xD;
          5. Patients with complicated diseases, including autoimmune disease, type I diabetes,&#xD;
             hypothyroidism requiring hormone replacement (except Hashimoto's thyroiditis) and&#xD;
             severe mental disease;&#xD;
&#xD;
          6. The patients received systemic corticosteroids (prednisone &gt; 10 mg/day or equivalent&#xD;
             dose) within 2 weeks before the first administration or patients who need systemic&#xD;
             corticosteroids therapy during the study;&#xD;
&#xD;
          7. The patients received radiotherapy, chemotherapy, hormone therapy, surgery, targeted&#xD;
             therapy or systemic treatment of antibody drugs within 4 weeks before the first&#xD;
             administration; the patients used monoclonal antibody coupled radionuclide or&#xD;
             cytotoxin therapy within 10 weeks before the first administration; the toxicity of the&#xD;
             previous anti-tumor treatment did not recover to ≤ level 1 (except hair loss);&#xD;
&#xD;
          8. Uncontrolled hypertension (systolic blood pressure &gt; 180mmHg and/or diastolic blood&#xD;
             pressure &gt; 100mmHg);&#xD;
&#xD;
          9. Previous history of organ transplantation or allogeneic hematopoietic stem cell&#xD;
             transplantation;&#xD;
&#xD;
         10. The patients who had autologous hematopoietic stem cell transplantation within 3&#xD;
             months before the first administration;&#xD;
&#xD;
         11. Patients receiving any attenuated vaccine within 4 weeks before the first&#xD;
             administration or during the study;&#xD;
&#xD;
         12. Patients who are allergic to macromolecular protein or anti-PD-1 antibody;&#xD;
&#xD;
         13. Patients who with previous or concurrent malignancies (except skin basal cell&#xD;
             carcinoma and cervical carcinoma in situ, which have been cured for more than 3&#xD;
             years);&#xD;
&#xD;
         14. Had uncontrollable or serious cardiovascular diseases, the heart of New YorkNYHA&#xD;
             standard grade 3-4 history of chronic heart failure, unstable angina, myocardial&#xD;
             infarction and other cardiovascular diseases within 6 months before the first&#xD;
             administration;&#xD;
&#xD;
         15. HIV positive patients, or active hepatitis (hepatitis B: hepatitis B five items and&#xD;
             HBV-DNA, transaminase, etc., hepatitis C: HCV antibody and HCV RNA);&#xD;
&#xD;
         16. Patients who had been previously treated with any other investigational drugs/devices&#xD;
             within 4 weeks before the first administration;&#xD;
&#xD;
         17. Patients with drug abuse history or alcohol addiction history within 6 months before&#xD;
             the first administration;&#xD;
&#xD;
         18. Patients who were previously treated with anti PD-1 antibody, anti PD-L1 antibody,&#xD;
             anti PD-L2 antibody, anti-137 or anti CTLA-4 antibody (or any other antibodies acting&#xD;
             on T cell co-stimulation or checkpoint pathway);&#xD;
&#xD;
         19. Patients with current or previous interstitial lung diseases (except for interstitial&#xD;
             lung disease caused by radiotherapy and chemotherapy and currently without symptoms);&#xD;
&#xD;
         20. Active infections requiring systemic treatment;&#xD;
&#xD;
         21. Patients with active pulmonary tuberculosis;&#xD;
&#xD;
         22. pregnant or lactating women, female patients with pregnancy plan or male patients with&#xD;
             such plan from the study period to 6 months after the last medication, who are&#xD;
             unwilling to use an effective contraceptive measure (such as IUD or condom) approved&#xD;
             by medicine during the trial period;&#xD;
&#xD;
         23. Subjects who are considered unsuitable for participating in this study for various&#xD;
             reasons at the discretion of the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>October 19, 2020</last_update_submitted>
  <last_update_submitted_qc>October 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Lymphoma, T-Cell</mesh_term>
    <mesh_term>Lymphoma, T-Cell, Peripheral</mesh_term>
  </condition_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/NCT04457830
org study id: NTP-F520-002
nct id: NCT04457830
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
It is a multi-center, prospective, open-label, two-stage optimized design, single-arm, phase
      II clinical study to evaluate the efficacy and safety of F520 for the treatment of relapsed
      and refractory peripheral T cell lymphoma (PTCL), and to evaluate the immunogenicity of F520.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: F520
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate (ORR)
time frame: Approximately 24 months
description: To evaluate the efficacy of F520 as defined by objective response rate (evaluated by IRC) in patients with relapsed or refractory PTCL.
measure: Objective response rate (ORR)
time frame: Approximately 24 months
description: To evaluate the efficacy of F520 as defined by objective response rate (evaluated by investigator) in patients with relapsed or refractory PTCL.
measure: Completed response rate (CRR)
time frame: Approximately 24 months
description: To evaluate the efficacy of F520 as defined by completed response rate (evaluated by investigator/IRC) in patients with relapsed or refractory PTCL.
measure: Duration of response (DOR)
time frame: Approximately 24 months
description: To evaluate the duration of response (DOR) of F520 in patients with relapsed or refractory PTCL.
measure: Overall survival (OS)
time frame: Approximately 24 months
description: To evaluate the duration from the first administration to death because of any reason in patients with relapsed or refractory PTCL.
measure: Progression-free survival (PFS)
time frame: Approximately 24 months
description: To evaluate the efficacy of F520 as defined by progression-free survival, in patients with relapsed or refractory PTCL.
measure: Disease control rate (DCR)
time frame: Approximately 24 months
description: To evaluate the efficacy of F520 as defined by disease control rate, in patients with relapsed or refractory PTCL.
measure: Time to response (TTR)
time frame: Approximately 24 months
description: To evaluate the efficacy of F520 as defined by time to response in patients with relapsed or refractory PTCL.
arm group label: Single arm
arm group type: Experimental
intervention type: Drug
intervention name: F520
description: 3mg/kg every 3 weeks
arm group label: Single arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Lymphoma, T-Cell
mesh term: Lymphoma, T-Cell, Peripheral