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/NCT06008405</url>
    </required_header>
    <id_info>
      <org_study_id>TQB2928-Ib-01</org_study_id>
      <nct_id>NCT06008405</nct_id>
    </id_info>
    <brief_title>Clinical Trial Evaluating the Safety of the TQB2928 Injection Combination Therapy</brief_title>
    <official_title>Phase Ib Clinical Trial of TQB2928 Injection Combination Therapy in Patients With Hematological Malignancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chia Tai Tianqing Pharmaceutical Group Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chia Tai Tianqing Pharmaceutical Group 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>
        This study carried out a phase Ib clinical trial of TQB2928 injection combined therapy in&#xD;
        patients with hematological malignancies, to explore the safety, pharmacokinetics,&#xD;
        pharmacodynamics and preliminary efficacy of TQB2928 injection combined with azacitidine for&#xD;
        injection in Acute Myeloid Leukemia (AML)/Myelodysplastic Syndromes (MDS) subjects.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2025</completion_date>
    <primary_completion_date type="Anticipated">May 2025</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>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of Adverse Events (AEs)</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>Adverse events refer to all adverse medical events that occur after patients receive the experimental drug, which can be manifested as symptoms, signs, diseases or abnormal laboratory tests, but do not necessarily have a causal relationship with the experimental drug. Evaluated by Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of serious adverse events (SAEs)</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>Incidence of serious adverse events (SAEs) evaluated by CTCAE 5.0.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Severity of serious adverse events (SAEs)</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>Severity of serious adverse events (SAEs) evaluated by CTCAE 5.0.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The area under the curve (AUC)</measure>
      <time_frame>Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.</time_frame>
      <description>The area under the curve (AUC) of serum or plasma concentration of TQB2928</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak concentration (Cmax)</measure>
      <time_frame>Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.</time_frame>
      <description>Maximum observed concentration of TQB2928</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peak Time (Tmax)</measure>
      <time_frame>Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.</time_frame>
      <description>Time to reach maximum concentration of TQB2928</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of anti-drug antibody (ADA)</measure>
      <time_frame>Cycle1 Day1 and Cycle 5 Day 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; 90 days after last dose; Each cycle is 28 days.</time_frame>
      <description>Incidence of anti-drug antibody (ADA)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AML: Objective Response Rate (ORR)</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>Defined as the percentage of Complete Response (CR) plus partial response (PR) plus Complete Response with incomplete hematological recovery (CRi) plus Morphological absence of leukemia status (MLFS) plus Complete Response with incomplete hematological recovery (CRh)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AML: Duration of Response (DOR)</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>For all patients with a best response of CR, CRh, CRi, MLFS, or PR, the time from the date of first achieved remission to the date of first documented disease progression/relapse/treatment failure or death, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AML: Time to CR+CRh+CRi</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>The time from the date of first TQB2928 injection treatment to the date of first CR, CRh or CRi among all patients whose best response was CR, CRh or CRi.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AML: Event-free survival (EFS)</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>Refers to the time from the date of receiving the first TQB2928 injection treatment to the first clearly recorded date of recurrence after remission, disease progression/treatment failure or death, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AML: Relapse-Free Survival (RFS)</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>Refers to the time from the date of remission to the first clearly recorded hematological relapse or death from any cause for patients who have achieved CR, CRh, or CRi, whichever occurs first.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>AML: Overall survival (OS)</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>The time from the date of receiving the first TQB2928 injection treatment to the date of death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MDS: Complete Response (CR) Rate</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>Proportion of patients whose best response is Complete Response</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MDS: Objective Response Rate (ORR)</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>Proportion of patients with best response in CR, Complete molecular remission (mCR), PR or hematological remission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MDS: Improvement in Transfusion Independence</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>Proportion of patients who were transfusion dependent at baseline who were free of red-blood-cell (RBC)/platelet transfusion after first dose.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MDS: Progression Free Survival (PFS)</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>From the date of receiving the first TQB2928 injection treatment to the first documented time to investigator-assessed disease progression/relapse after CR or death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MDS: Leukemia-free survival</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>From the date of receiving the first TQB2928 injection treatment to the blast cells in bone marrow/peripheral blood exceeding 20%, or the time of diagnosis of extramedullary acute leukemia, or death due to any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MDS: Change from Baseline in Quality of Life (QoL) Score</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>Proportion of patients with a confirmed improvement of at least 10 points from baseline in overall health status/ QoL score assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MDS: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue</measure>
      <time_frame>Up to 2 years.</time_frame>
      <description>Proportion of patients with confirmed improvement of at least 3 points from baseline in FACIT-Fatigue score</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Acute Myeloid Leukemia</condition>
    <condition>Myelodysplastic Syndromes</condition>
    <arm_group>
      <arm_group_label>TQB2928 Injection + Azacitidine for injection</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dose escalation:&#xD;
  Intravenous infusion of TQB2928 Injection once a week, combined with azacitidine for injection (75 mg/m2, d1-7/q4w), 4 weeks (28 days) as a treatment cycle.&#xD;
  Dose expansion:&#xD;
  The maximum tolerated dose (MTD) or optimal biological dose (OBD) or recommended phase II dose (RP2D) determined in the dose-escalation phase is combined with azacitidine for injection for extended studies to further observe the safety and efficacy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TQB2928 Injection + Azacitidine for injection</intervention_name>
      <description>TQB2928 injection is a fully humanized Immunoglobulin G 4 (IgG4) subtype monoclonal antibody targeting CD47.&#xD;
  Azacitidine for injection is a nucleoside metabolism inhibitor that inhibits DeoxyriboNucleic Acid (DNA) methyltransferase, reduces DNA methylation and alters gene expression.</description>
      <arm_group_label>TQB2928 Injection + Azacitidine for injection</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects voluntarily join this study, sign the informed consent form, and have good&#xD;
               compliance;&#xD;
  &#xD;
            -  Age: age ≥ 18 years old (when signing the informed consent); Eastern Cooperative&#xD;
               Oncology Group Performance Status (ECOG PS) score: 0-2 points; expected survival time&#xD;
               of more than 3 months;&#xD;
  &#xD;
            -  Subject population:&#xD;
  &#xD;
                 1. The subjects were diagnosed with AML or MDS according to the World Health&#xD;
                    Organization (WHO) 2016 revised classification criteria for hematopoietic and&#xD;
                    lymphoid tissue tumors.&#xD;
  &#xD;
                 2. MDS adopts the revised International Prognostic Scoring System (IPSS-R) &gt; 3.5&#xD;
                    (higher risk group), and the proportion of bone marrow blasts ≥ 5%.&#xD;
  &#xD;
                 3. Phase 1 (dose escalation phase) and Phase 2 (dose expansion phase) enrollment&#xD;
  &#xD;
                      1. Untreated AML who cannot tolerate standard induction chemotherapy;&#xD;
  &#xD;
                      2. Untreated higher-risk MDS;&#xD;
  &#xD;
            -  The main organs function well.&#xD;
  &#xD;
            -  Subjects must be willing to provide available diagnostic evidence or perform bone&#xD;
               marrow aspiration and biopsy before the study treatment and must be willing to perform&#xD;
               bone marrow aspiration and biopsy after receiving the study treatment.&#xD;
  &#xD;
            -  Female subjects of childbearing age should agree to use contraceptive measures (such&#xD;
               as intrauterine devices, contraceptives or condoms) during the study period and within&#xD;
               6 months after the end of the study; negative serum pregnancy test within 7 days&#xD;
               before study enrollment, and must be non-lactating subjects; male subjects should&#xD;
               agree to use contraceptive measures during the study period and within 6 months after&#xD;
               the end of the study period.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Tumor disease and medical history:&#xD;
  &#xD;
                 1. central nervous system leukemia;&#xD;
  &#xD;
                 2. Other malignant tumors have occurred or are currently suffering from other&#xD;
                    malignant tumors within 3 years. The following two conditions can be included:&#xD;
                    other malignancies treated by a single surgery, achieving 5 years of continuous&#xD;
                    disease-free survival (DFS);&#xD;
  &#xD;
                 3. Clinically significant uncontrolled pleural effusion, ascites, moderate or more&#xD;
                    remarkable pericardial effusion requiring repeated drainage.&#xD;
  &#xD;
            -  Previous anti-tumor therapy:&#xD;
  &#xD;
                 1. Previous use of other drugs targeting the CD47/signal-regulatory protein α&#xD;
                    (SIRPα) signaling pathway;&#xD;
  &#xD;
                 2. Received any antibody drug treatment under investigation within 4 weeks before&#xD;
                    the first administration, received Chimeric Antigen Receptor -T (CAR-T) therapy,&#xD;
                    or other immune cell therapy, or autologous hematopoietic stem cell&#xD;
                    transplantation 3 months before the first administration;&#xD;
  &#xD;
                 3. Previously received allogeneic hematopoietic stem cell transplantation;&#xD;
  &#xD;
                 4. Received any major surgery, chemotherapy and/or radiotherapy, immunotherapy or&#xD;
                    targeted therapy within 4 weeks before the first administration;&#xD;
  &#xD;
                 5. The first administration is less than 5 drug half-lives from the previous oral&#xD;
                    targeted therapy (calculated from the end of the last treatment);&#xD;
  &#xD;
                 6. Received Chinese patent medicines with anti-tumor indications within 2 weeks&#xD;
                    before the first administration, including compound mylabris capsules, Kangai&#xD;
                    injection, Kanglaite capsule/injection, Aidi injection, javanica oil, Xiao'ai&#xD;
                    ping tablet/injection, cinobufagin capsule, etc., (using symptomatic treatment&#xD;
                    such as hydroxyurea, leukocyte apheresis and erythropoietin and other&#xD;
                    hematopoietic growth factors within 7 days is allowed);&#xD;
  &#xD;
            -  Combined diseases and medical history:&#xD;
  &#xD;
                 1. Liver abnormalities:&#xD;
  &#xD;
                      1. Decompensated cirrhosis (Child-Pugh liver function grade B or C);&#xD;
  &#xD;
                      2. Hepatitis B virus infection;&#xD;
  &#xD;
                      3. Hepatitis C virus infection;&#xD;
  &#xD;
                 2. Kidney abnormalities:&#xD;
  &#xD;
                      1. Renal failure requires hemodialysis or peritoneal dialysis;&#xD;
  &#xD;
                      2. history of nephrotic syndrome.&#xD;
  &#xD;
                 3. Gastrointestinal abnormalities:&#xD;
  &#xD;
                      1. Persistent chronic diarrhea despite maximal medical treatment;&#xD;
  &#xD;
                      2. Active inflammatory bowel disease (such as ulcerative colitis, Crohn's&#xD;
                         disease) within 4 weeks before the first dose.&#xD;
  &#xD;
                 4. Cardiovascular and cerebrovascular abnormalities:&#xD;
  &#xD;
                      1. Concomitant or previous history of central nervous system disease, including&#xD;
                         seizures, hemorrhagic/ischemic stroke, severe brain injury, dementia,&#xD;
                         Parkinson's disease, cerebellar disease, paralysis, aphasia, mental illness,&#xD;
                         disturbance of consciousness, unknown Cause coma, neuropathy, organic brain&#xD;
                         syndrome, etc.;&#xD;
  &#xD;
                      2. Brain Magnetic Resonance Imaging (MRI) evidence of inflammatory lesions&#xD;
                         and/or vasculitis;&#xD;
  &#xD;
                      3. Cerebrovascular accident, cerebral infarction, etc., occurred within 6&#xD;
                         months before the first administration;&#xD;
  &#xD;
                      4. Arterial/venous thrombosis events such as deep vein thrombosis and pulmonary&#xD;
                         embolism occurred within 6 months before the first administration;&#xD;
  &#xD;
                      5. Accompanying or previous history of cardiovascular disease, including grade&#xD;
                         III or IV heart failure defined by the New York Heart Association&#xD;
                         classification, atrioventricular block of grade II and above, myocardial&#xD;
                         infarction within 6 months before the first dose, severe History of&#xD;
                         arrhythmia, unstable angina, etc.;&#xD;
  &#xD;
                      6. Hypertension that cannot be controlled by the combination of two drugs (at&#xD;
                         least 2 measurements are systolic blood pressure ≥ 160 mmHg, diastolic blood&#xD;
                         pressure ≥ 100 mmHg);&#xD;
  &#xD;
                      7. Previously or currently suffering from heart valvulitis and endarteritis.&#xD;
  &#xD;
                 5. History of immunodeficiency:&#xD;
  &#xD;
                      1. Known human immunodeficiency virus (HIV) infection or other acquired or&#xD;
                         congenital immunodeficiency diseases;&#xD;
  &#xD;
                      2. Prepare to undergo or have previously received organ transplantation or have&#xD;
                         noticeable host transplantation reactions;&#xD;
  &#xD;
                      3. Need to receive systemic immunosuppressant therapy, including but not&#xD;
                         limited to the use of cyclosporine, tacrolimus, etc., within 4 weeks before&#xD;
                         the first administration, and receive high-dose glucocorticoid therapy&#xD;
                         (prednisone &gt;30 mg /day or other glucocorticoids at equivalent doses), or&#xD;
                         those with autoimmune diseases, allergic diseases or immune rejection&#xD;
                         receiving any other immunosuppressive therapy. Patients receiving inhaled or&#xD;
                         topical corticosteroids or prednisone &lt; 10 mg/day or equivalent doses of&#xD;
                         other systemic corticosteroids at a stable dose for at least 4 weeks before&#xD;
                         the first dose or receiving Prophylactic medication to prevent infusion&#xD;
                         reactions can be selected.&#xD;
  &#xD;
                 6. Uncontrolled active systemic bacterial, fungal, or viral infection.&#xD;
  &#xD;
                 7. Unexplained fever &gt; 38.5 ℃ occurred during screening or before the first&#xD;
                    medication (except for fever caused by tumors judged by the investigator).&#xD;
  &#xD;
                 8. Subjects with any history of hemolytic anemia (including Evans syndrome) or&#xD;
                    positive Coombs test within 3 months before the first administration.&#xD;
  &#xD;
                 9. Lung disease:&#xD;
  &#xD;
                      1. Blood oxygen saturation ≤ 95% at rest;&#xD;
  &#xD;
                      2. Previous or current noninfectious pneumonia requiring corticosteroid therapy&#xD;
                         (including but not limited to acute respiratory distress syndrome, acute&#xD;
                         hypersensitivity pneumonia, drug-associated pneumonia, bronchospasm, acute&#xD;
                         interstitial pneumonia, idiopathic pulmonary interstitial fibrosis, etc.);&#xD;
  &#xD;
                      3. Evidence of active pneumonia found on chest Computed Tomography (CT) scan&#xD;
                         during the screening period;&#xD;
  &#xD;
                      4. Active tuberculosis.&#xD;
  &#xD;
                10. A history of severe allergies of unknown causes; known allergies to monoclonal&#xD;
                    antibody drugs or exogenous human immunoglobulins; known allergies to study drug&#xD;
                    excipients.&#xD;
  &#xD;
                11. Combined with serious or not well-controlled concomitant diseases that, according&#xD;
                    to the investigator's judgment, seriously endanger the subject's safety or affect&#xD;
                    the study's completion.&#xD;
  &#xD;
                12. With or previous history of pituitary or adrenal dysfunction (as assessed by the&#xD;
                    investigator).&#xD;
  &#xD;
                13. History of drug abuse or drug abuse.&#xD;
  &#xD;
                14. myelodysplastic syndromes (MDS) subjects combined with the following two&#xD;
                    conditions: uncorrected folic acid and vitamin B12 deficiency MDS transformed&#xD;
                    from pre-existing myeloproliferative neoplasms (MPN) or MDS/MPN types that meet&#xD;
                    the World Health Organization (WHO) 2016 classification criteria, including&#xD;
                    chronic Myeloid leukemia (CMML), atypical chronic myeloid leukemia (CML),&#xD;
                    juvenile myeloid leukemia (JMML).&#xD;
  &#xD;
                15. M3 type acute myeloid leukemia (AML) and AML with positive BCR-ABL mutation gene.&#xD;
  &#xD;
            -  Inoculation within 4 weeks before the first administration or vaccination with live&#xD;
               attenuated vaccine during the planned study period.&#xD;
  &#xD;
            -  Participated in other drug clinical trials within the past 30 days.&#xD;
  &#xD;
            -  It is estimated that the compliance of patients participating in this clinical&#xD;
               research needs to be improved.&#xD;
  &#xD;
            -  Hypersensitivity to azacitidine or mannitol;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Weili Zhao, Doctor</last_name>
      <phone>+86 021-64150275</phone>
      <email>zwl_trail@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hongyan Tong, Doctor</last_name>
      <phone>+86 18120165251</phone>
      <email>tonghongyan@zju.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking University People's Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100044</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hao Jiang, Doctor</last_name>
        <phone>+86 13601164350</phone>
        <email>Jiangha0090@sina.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Chongqing Hospital of Traditional Chinese Medicine</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400011</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Weiqi Nian, Doctor</last_name>
        <phone>13883652913</phone>
        <email>nwqone@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Henan Cancer Hospital</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xudong Wei, Doctor</last_name>
        <phone>+86 13837169301</phone>
        <email>weixudong63@126.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Third Xiangya Hospital of Central South University</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410013</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Ying Li, Doctor</last_name>
        <phone>+86 13607499962</phone>
        <email>13538563@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Nanchang University</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <zip>330006</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Fei Li, Doctor</last_name>
        <phone>+86 13970038386</phone>
        <email>lifeigcp2022@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Hospital of Jilin University</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <zip>130021</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Sujun Gao, Doctor</last_name>
        <phone>+86 15843073208</phone>
        <email>sujung1963@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of China Medical University</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xiaojing Yan, Doctor</last_name>
        <phone>+86 13889128302.</phone>
        <email>13538563@qq.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanghai Jiaotong University, School of Medicine, Ruijin Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200025</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Weili Zhao, Doctor</last_name>
        <phone>+862164150275</phone>
        <email>zwl_trail@163.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310006</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hongyan Tong, Doctor</last_name>
        <phone>+8618120165251</phone>
        <email>tonghongyan@zju.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</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>Myelodysplastic Syndromes</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Azacitidine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06008405
  org study id: TQB2928-Ib-01
  nct id: NCT06008405
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study carried out a phase Ib clinical trial of TQB2928 injection combined therapy in
        patients with hematological malignancies, to explore the safety, pharmacokinetics,
        pharmacodynamics and preliminary efficacy of TQB2928 injection combined with azacitidine for
        injection in Acute Myeloid Leukemia (AML)/Myelodysplastic Syndromes (MDS) subjects.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Incidence of Adverse Events (AEs)
  time frame: Up to 2 years.
  description: Adverse events refer to all adverse medical events that occur after patients receive the experimental drug, which can be manifested as symptoms, signs, diseases or abnormal laboratory tests, but do not necessarily have a causal relationship with the experimental drug. Evaluated by Common Terminology Criteria for Adverse Events 5.0 (CTCAE 5.0).
  measure: Incidence of serious adverse events (SAEs)
  time frame: Up to 2 years.
  description: Incidence of serious adverse events (SAEs) evaluated by CTCAE 5.0.
  measure: Severity of serious adverse events (SAEs)
  time frame: Up to 2 years.
  description: Severity of serious adverse events (SAEs) evaluated by CTCAE 5.0.
  measure: The area under the curve (AUC)
  time frame: Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.
  description: The area under the curve (AUC) of serum or plasma concentration of TQB2928
  measure: Peak concentration (Cmax)
  time frame: Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.
  description: Maximum observed concentration of TQB2928
  measure: Peak Time (Tmax)
  time frame: Day1 and Day 22 of Cycle 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; Cycle 1 Day 8, Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15: pre-dose, 5 min after dose; 90 days after last dose; Each cycle is 28 days.
  description: Time to reach maximum concentration of TQB2928
  measure: Incidence of anti-drug antibody (ADA)
  time frame: Cycle1 Day1 and Cycle 5 Day 1: pre-dose, 5 min, 2 h, 6 h, 24 h, 72 h, 120 hours after dose; 90 days after last dose; Each cycle is 28 days.
  description: Incidence of anti-drug antibody (ADA)
  measure: AML: Objective Response Rate (ORR)
  time frame: Up to 2 years.
  description: Defined as the percentage of Complete Response (CR) plus partial response (PR) plus Complete Response with incomplete hematological recovery (CRi) plus Morphological absence of leukemia status (MLFS) plus Complete Response with incomplete hematological recovery (CRh)
  measure: AML: Duration of Response (DOR)
  time frame: Up to 2 years.
  description: For all patients with a best response of CR, CRh, CRi, MLFS, or PR, the time from the date of first achieved remission to the date of first documented disease progression/relapse/treatment failure or death, whichever occurs first.
  measure: AML: Time to CR+CRh+CRi
  time frame: Up to 2 years.
  description: The time from the date of first TQB2928 injection treatment to the date of first CR, CRh or CRi among all patients whose best response was CR, CRh or CRi.
  measure: AML: Event-free survival (EFS)
  time frame: Up to 2 years.
  description: Refers to the time from the date of receiving the first TQB2928 injection treatment to the first clearly recorded date of recurrence after remission, disease progression/treatment failure or death, whichever occurs first.
  measure: AML: Relapse-Free Survival (RFS)
  time frame: Up to 2 years.
  description: Refers to the time from the date of remission to the first clearly recorded hematological relapse or death from any cause for patients who have achieved CR, CRh, or CRi, whichever occurs first.
  measure: AML: Overall survival (OS)
  time frame: Up to 2 years.
  description: The time from the date of receiving the first TQB2928 injection treatment to the date of death from any cause.
  measure: MDS: Complete Response (CR) Rate
  time frame: Up to 2 years.
  description: Proportion of patients whose best response is Complete Response
  measure: MDS: Objective Response Rate (ORR)
  time frame: Up to 2 years.
  description: Proportion of patients with best response in CR, Complete molecular remission (mCR), PR or hematological remission
  measure: MDS: Improvement in Transfusion Independence
  time frame: Up to 2 years.
  description: Proportion of patients who were transfusion dependent at baseline who were free of red-blood-cell (RBC)/platelet transfusion after first dose.
  measure: MDS: Progression Free Survival (PFS)
  time frame: Up to 2 years.
  description: From the date of receiving the first TQB2928 injection treatment to the first documented time to investigator-assessed disease progression/relapse after CR or death from any cause.
  measure: MDS: Leukemia-free survival
  time frame: Up to 2 years.
  description: From the date of receiving the first TQB2928 injection treatment to the blast cells in bone marrow/peripheral blood exceeding 20%, or the time of diagnosis of extramedullary acute leukemia, or death due to any cause.
  measure: MDS: Change from Baseline in Quality of Life (QoL) Score
  time frame: Up to 2 years.
  description: Proportion of patients with a confirmed improvement of at least 10 points from baseline in overall health status/ QoL score assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-C30 (QLQ-C30)
  measure: MDS: Change from Baseline in the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
  time frame: Up to 2 years.
  description: Proportion of patients with confirmed improvement of at least 3 points from baseline in FACIT-Fatigue score
  arm group label: TQB2928 Injection + Azacitidine for injection
  arm group type: Experimental
  description: Dose escalation:
  Intravenous infusion of TQB2928 Injection once a week, combined with azacitidine for injection (75 mg/m2, d1-7/q4w), 4 weeks (28 days) as a treatment cycle.
  Dose expansion:
  The maximum tolerated dose (MTD) or optimal biological dose (OBD) or recommended phase II dose (RP2D) determined in the dose-escalation phase is combined with azacitidine for injection for extended studies to further observe the safety and efficacy.
  intervention type: Drug
  intervention name: TQB2928 Injection + Azacitidine for injection
  description: TQB2928 injection is a fully humanized Immunoglobulin G 4 (IgG4) subtype monoclonal antibody targeting CD47.
  Azacitidine for injection is a nucleoside metabolism inhibitor that inhibits DeoxyriboNucleic Acid (DNA) methyltransferase, reduces DNA methylation and alters gene expression.
  arm group label: TQB2928 Injection + Azacitidine for injection
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Weili Zhao, Doctor
  phone: +86 021-64150275
  email: zwl_trail@163.com
  last name: Hongyan Tong, Doctor
  phone: +86 18120165251
  email: tonghongyan@zju.edu.cn
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Myelodysplastic Syndromes
  mesh term: Azacitidine