<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/NCT03034304</url>
  </required_header>
  <id_info>
    <org_study_id>HRYZ MASCT-I-1001</org_study_id>
    <nct_id>NCT03034304</nct_id>
  </id_info>
  <brief_title>A Phase I Clinical Study for Evaluating the Safety and Efficacy of MASCT-I in Patients With Advanced Solid Tumors</brief_title>
  <official_title>Multi-center, Phase I Clinical Study to Evaluate the Safety and Tolerability of Multi-antigen Autologous Immune Cell Injection (MASCT-I) in Patients With Advanced Solid Tumor, and to Preliminarily Evaluate the Anti-tumor Efficacy of MASCT-I Alone, in Combination With Chemical Drugs, and in Combination With PD1 Antibody</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SYZ Cell Therapy Co..</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SYZ Cell Therapy Co..</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate Safety and tolerability of MASCT-I in patients with&#xD;
      advanced solid tumors, either alone or in combination with chemical drugs or in combination&#xD;
      with PD1 antibody.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The multiple-antigen specific cell therapy which was developed by Hengrui Yuanzheng is&#xD;
      optimized continuously and has been upgraded from the first-generation MASCT technology to&#xD;
      MASCT-I. MASCT-I is a technology which add PD1 antibody in vitro cell culture process of&#xD;
      MASCT cell culture to block PD1 receptor on immunocytes, release the brake on immunocytes'&#xD;
      reinfusion and interaction with tumor cells for enhancing the efficacy of immunocytes'&#xD;
      killing tumor cells. At present, the development and validation of manufacturing process has&#xD;
      been completed, and it is urgently needed to conduct the validation of clinical effect.&#xD;
&#xD;
      This is a Multi-center, phase I clinical study to evaluate the safety and tolerability of&#xD;
      multi-antigen autologous immune cell injection (MASCT-I) in patients with advanced solid&#xD;
      tumor, and to preliminarily evaluate the anti-tumor efficacy of MASCT-I alone, in combination&#xD;
      with chemical drugs, and in combination with PD1 antibody. About 193 cases of adult patients&#xD;
      with advanced solid tumors will be recruited.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">July 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2023</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 Treatment-Emergent Adverse Events(Safety)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>All the local reactions, systemic reactions, adverse events and serious adverse events of all the patients will be collected from the informed consent to the end of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events(Safety)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>All the local reactions, systemic reactions, adverse events and serious adverse events of all the patients will be collected from the the informed consent to the end of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate (DCR)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) based on RESIST v1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>The length of time from enrollment until the time of progression of disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>From enrollment to death of patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recurrence (TTR)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>the period of time from signing of the ICF by the patient to progression of tumor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>time to progression(TTP)</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>Time from the first successful apheresis to the first progression of the tumor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>up to 96 weeks</time_frame>
    <description>The percentage of subjects with PR or CR.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">193</enrollment>
  <condition>Advanced Solid Tumors</condition>
  <arm_group>
    <arm_group_label>MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1: MASCT-I alone;&#xD;
Group 2: Advanced urothelial carcinoma and cholangiocarcinoma treatment with MASCT-I alone,Advanced soft tissue sarcoma and osteosarcoma treatment with MASCT-I alone or combination with ifosfamide. In the event of disease progression, treatment with MASCT-I +PD1 antibody;&#xD;
Group 3: Advanced metastatic or recurrent urothelial carcinoma, soft tissue sarcoma/osteosarcoma, and cholangiocarcinoma that progressed after first line chemotherapy were treated with MASCT-I combined with PD1 antibody;&#xD;
Group 4: Recurrent metastatic solid tumors that had failed previous treatment with PD1 antibody were treated with MASCT-I + PD1 antibody;&#xD;
Group 5: Untreated advanced soft tissue sarcom treatment with MASCT-I+AI (Adriamycin+ifosfamide);&#xD;
Group 6: Untreated advanced urothelial carcinoma treatment with MASCT-I+GP/GC(Gemcitabine+cisplatin/ Gemcitabine+carboplatin);</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>MASCT-I</intervention_name>
    <description>The final products of MASCT-I technology are dendritic cells (DC) and effector T cells</description>
    <arm_group_label>MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ifosfamide</intervention_name>
    <description>2g/m2/d, intravenous drip for 30min. Administration is conducted for continuous 5 days. After 4 weeks, the above cycle is repeated for 6 continuous cycles</description>
    <arm_group_label>MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PD1 antibody</intervention_name>
    <description>200 mg/every two weeks ,four weeks is a cycle. Subjects were treated with MASCT-I combined with PD1 antibody until disease progression, MASCT-I intolerance or study completion. If PD1 antibody intolerance occurs, MASCT-I therapy alone will continue. MASCT-I and PD1 antibody are adminnistered according to their respective drug cycle without interfering with each other.</description>
    <arm_group_label>MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Adriamycin</intervention_name>
    <description>60mg/m2, from the first day of each cycle, it is used for 1-2 days, intravenous drip. Repeat the above cycle after 4 weeks, no more than 8 cycles</description>
    <arm_group_label>MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>1000 mg/m2, Intravenous drip for about 30 min, used on the first and eighth days of each cycle, and every 3-4 weeks as a cycle</description>
    <arm_group_label>MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>70mg/m2, Use on the first day of each chemotherapy cycle, intravenous drip for 30-120 min, and every 3-4 weeks as a cycle;</description>
    <arm_group_label>MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>5mg/ml/min, Use it on the first day of each chemotherapy cycle, intravenous drip for 30 minutes, and every 3-4 weeks as a cycle</description>
    <arm_group_label>MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Major Inclusion Criteria:&#xD;
&#xD;
          1. Age 18-70 at screening;&#xD;
&#xD;
          2. Obtain written informed consent of the subject/legal representative prior to&#xD;
             conducting any program related procedures, including evaluation during the screening&#xD;
             period;&#xD;
&#xD;
          3. Scored 0 -1 on ECOG;&#xD;
&#xD;
          4. Life expectancy ≥6 months;&#xD;
&#xD;
          5. Cardiopulmonary function is basically normal;&#xD;
&#xD;
          6. Results of blood test and biochemistry at baseline meeting the following&#xD;
             criteria:Hemoglobin≥85g/L,Leucocyte≥3.0×109/L,Absolute neutrophil&#xD;
             count(ANC)≥1.5×109/L,Trombocyte≥70×109/L,ALT/AST ≤ 2.5×ULN or ≤ 5×ULN for patients&#xD;
             with hepatic metastases, ALP≤2.5 times of upper limit of normal, Serum total bilirubin&#xD;
             &lt; 1.5×ULN,Serum urea nitrogen and creatinine ≤ 1.5×ULN,patients with urothelial&#xD;
             carcinoma,Serum urea nitrogen and creatinine ≤ 2.5×ULN, Serum albumin ≥30g/L&#xD;
&#xD;
        For the first group of subjects, the following criteria should be met:&#xD;
&#xD;
          1. Patients who suffer from advanced (unresectable) or recurrent solid tumors (only&#xD;
             limited to bladder cancer and soft tissue sarcoma) confirmed by histology and cytology&#xD;
             and are treated unsuccessfully with various standard therapies;&#xD;
&#xD;
          2. According to RECIST1.1 criteria, there must be one measurable focus;&#xD;
&#xD;
          3. Time interval between end of other anti-tumor measures and this study treatment is at&#xD;
             least 1 month;&#xD;
&#xD;
        For the second group of subjects, the following criteria should be met:&#xD;
&#xD;
          1. Urothelial carcinoma: histologically or cytologically confirmed that gemcitabine +&#xD;
             platinum-based first-line chemotherapy achieved clinical benefit after 4-6 cycles of&#xD;
             advanced recurrence or metastasis;&#xD;
&#xD;
          2. Soft tissue sarcoma or osteosarcoma: Subjects who histologically or cytologically&#xD;
             demonstrated clinical benefit after at least 4 cycles of doxorubicin-based first-line&#xD;
             chemotherapy following advanced recurrence or metastasis. For some subjects who are&#xD;
             intolerant or insensitive to chemotherapy, screening can also be conducted after other&#xD;
             first-line treatment regiments achieve clinical benefit.&#xD;
&#xD;
          3. Cholangiocarcinoma: Histologically or cytologically confirmed, first-line treatment&#xD;
             after advanced recurrence or metastasis is beneficial.&#xD;
&#xD;
        Note: Clinical benefit is defined as complete response (CR), partial response (PR), or&#xD;
        disease stabilization (SD). The disease stabilizes for more than 2 months.&#xD;
&#xD;
        For subjects in the third group, the following criteria should be met:&#xD;
&#xD;
          1. Urothelial carcinoma: histologically or cytologically confirmed disease progression&#xD;
             after advanced recurrence or metastasis following gemcitabine + platinum regimen&#xD;
             first-line chemotherapy;&#xD;
&#xD;
          2. Soft tissue sarcoma or osteosarcoma: histologically or cytologically confirmed disease&#xD;
             progression after advanced recurrence or metastasis followed by first-line&#xD;
             chemotherapy dominated by adriamycin; For some subjects who are intolerant or&#xD;
             insensitive to chemotherapy, they can also be screened after other first-line&#xD;
             treatment regiments fail.&#xD;
&#xD;
          3. Cholangiocarcinoma: histologically or cytologically confirmed, progression after&#xD;
             first-line treatment after advanced recurrence or metastasis;&#xD;
&#xD;
          4. According to RECIST1.1, at least one measurable lesion must be present;&#xD;
&#xD;
          5. An interval of at least 4 weeks between the end of other anticancer treatments and the&#xD;
             treatment in this study;&#xD;
&#xD;
        For the fourth group of subjects, the following criteria should be met:&#xD;
&#xD;
          1. Solid tumor with advanced recurrence or metastasis;&#xD;
&#xD;
          2. PD1 antibody therapy has been used before, and the disease is progressing. The&#xD;
             interval between the end of PD1 antibody therapy and this study is at least 4 weeks;&#xD;
&#xD;
          3. According to RECIST1.1, at least one measurable lesion must be present;&#xD;
&#xD;
          4. The interval between the end of other anticancer treatments and the treatment in this&#xD;
             study should be at least 4 weeks;&#xD;
&#xD;
        For the fifth group of subjects, the following criteria should be met:&#xD;
&#xD;
          1. Subjects with pathologically confirmed soft tissue sarcoma, locally advanced or&#xD;
             metastatic, and inoperable, have not undergone systemic treatment;&#xD;
&#xD;
          2. According to RECIST1.1, at least one measurable lesion must be present&#xD;
&#xD;
        For the sixth group of subjects, the following criteria should be met:&#xD;
&#xD;
          1. Histologically or cytologically confirmed inoperable locally advanced or metastatic&#xD;
             urothelial carcinoma (T4b, any N; Or any T, N 2-3) or metastatic urothelial carcinoma&#xD;
             (M1, stage IV) including renal pelvis, ureter, bladder, and urethra);&#xD;
&#xD;
          2. Had not previously received systemic chemotherapy for locally advanced or metastatic&#xD;
             urothelial carcinoma (UC);&#xD;
&#xD;
          3. At least one measurable lesion was evaluated (based on RECIST1.1 criteria); If the&#xD;
             measurable lesion has previously undergone radiotherapy, it needs to be clearly&#xD;
             documented that it is now a lesion after disease progression.&#xD;
&#xD;
          4. For subjects who had previously received local intravesical infusion chemotherapy or&#xD;
             immunotherapy, this local therapy needed to be completed at least 4 weeks prior to the&#xD;
             initiation of the first chemotherapy in this trial&#xD;
&#xD;
          5. Glomerular filtration rate ≥30ml/ min (creatinine clearance was calculated using the&#xD;
             standard Cockcroft-Gault formula);&#xD;
&#xD;
        Major Exclusion Criteria:&#xD;
&#xD;
          1. Subjects have clinically manifested central nervous system metastases (such as brain&#xD;
             edema, need for hormonal intervention, or progression of brain metastases). Subjects&#xD;
             who have received previous treatment for brain or meningeal metastasis, such as&#xD;
             clinical stability (MRI) for at least 2 months, and have ceased systemic sex hormone&#xD;
             therapy (&gt;10mg/ day prednisone or other therapeutic hormones) for more than 2 weeks&#xD;
             may be included;&#xD;
&#xD;
          2. Subjects are receiving immunosuppressive, or systemic, or absorbable local hormone&#xD;
             therapy for immunosuppression purposes (&gt;10mg/ day prednisone or other therapeutic&#xD;
             hormones) and continue to receive such therapy within 2 weeks prior to enrollment;&#xD;
&#xD;
          3. Subjects are taking immunomodulator drugs and continue to use them within 2 weeks&#xD;
             prior to enrollment;&#xD;
&#xD;
          4. Subjects have received MASCT or other cellular immunotherapy or PD1 antibody therapy&#xD;
             in the previous year (subjects in the fourth group are not limited to PD1 antibody&#xD;
             therapy);&#xD;
&#xD;
          5. Subject has any active autoimmune disease or a history of autoimmune disease;&#xD;
&#xD;
          6. The subject has active tuberculosis;&#xD;
&#xD;
          7. Subject has hepatitis C or HIV infection, or syphilis infection;&#xD;
&#xD;
          8. Patients with gastrointestinal stromal tumor, Ewing sarcoma and rhabdomyosarcoma&#xD;
&#xD;
          9. Patients with recurrence or metastasis during the adjuvant treatment after radical&#xD;
             surgery or within 6 months after the end of the treatment (only for patients in Group&#xD;
             5 and Group 6):&#xD;
&#xD;
         10. Those who have used targeted therapy, radiotherapy, immunotherapy or other treatment&#xD;
             schemes with clear anti-tumor effect within 4 weeks before enrollment, such as&#xD;
             arrotinib, gemcitabine and traditional Chinese medicine; However, if the focus of&#xD;
             radiotherapy is not a target focus or there is clear progress after radiotherapy, it&#xD;
             can be considered to be included in the group (only for the fifth and sixth groups of&#xD;
             subjects);&#xD;
&#xD;
         11. Those who are not suitable for treatment with A1 scheme (only for the fifth group of&#xD;
             subjects)&#xD;
&#xD;
         12. Hearing impairment with CTCAE grade&gt;2 (for the sixth group)&#xD;
&#xD;
         13. Peripheral neuropathy with CTCAE grade &gt;2 (such as sensory degeneration, sensory&#xD;
             abnormality, including tingling sensation) (for the sixth group);&#xD;
&#xD;
         14. The investigators believed that the subjects were not suitable for chemotherapy&#xD;
             containing platinum or gemcitabine (for the sixth group);&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ruihua Xu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sun Yat-sen University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Xuemin Rao</last_name>
    <phone>021-61049928</phone>
    <email>raoxuemin@shhryz.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fendi Yang</last_name>
    <email>yangfendi@shhryz.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Sun Yat-sen University Cancer Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fendi Yang</last_name>
      <email>yangfendi@shhryz.com</email>
    </contact>
    <investigator>
      <last_name>Ruihua Xu, doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital Affiliated to Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Ruijin Hospital, Shanghai Jiaotong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Fendi Yang, master</last_name>
      <email>yangfendi@shhryz.com</email>
    </contact>
    <investigator>
      <last_name>Weibin Zhang, doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shanghai Sixth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Shanghai Tenth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Fendi Yang, master</last_name>
      <email>yangfendi@shhryz.com</email>
    </contact>
    <investigator>
      <last_name>Qing Xu, doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tianjin Cancer Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Fendi Yang, master</last_name>
      <email>yangfendi@shhryz.com</email>
    </contact>
    <investigator>
      <last_name>Zhaoming Ye, doctor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Zhejiang Tumor Hospita</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>December 29, 2022</last_update_submitted>
  <last_update_submitted_qc>December 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>MASCT-I,DC,T cell</keyword>
  <keyword>Advanced solid tumors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Doxorubicin</mesh_term>
    <mesh_term>Liposomal doxorubicin</mesh_term>
    <mesh_term>Ifosfamide</mesh_term>
    <mesh_term>Antibodies</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03034304
org study id: HRYZ MASCT-I-1001
nct id: NCT03034304
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate Safety and tolerability of MASCT-I in patients with
      advanced solid tumors, either alone or in combination with chemical drugs or in combination
      with PD1 antibody.
The multiple-antigen specific cell therapy which was developed by Hengrui Yuanzheng is
      optimized continuously and has been upgraded from the first-generation MASCT technology to
      MASCT-I. MASCT-I is a technology which add PD1 antibody in vitro cell culture process of
      MASCT cell culture to block PD1 receptor on immunocytes, release the brake on immunocytes'
      reinfusion and interaction with tumor cells for enhancing the efficacy of immunocytes'
      killing tumor cells. At present, the development and validation of manufacturing process has
      been completed, and it is urgently needed to conduct the validation of clinical effect.

      This is a Multi-center, phase I clinical study to evaluate the safety and tolerability of
      multi-antigen autologous immune cell injection (MASCT-I) in patients with advanced solid
      tumor, and to preliminarily evaluate the anti-tumor efficacy of MASCT-I alone, in combination
      with chemical drugs, and in combination with PD1 antibody. About 193 cases of adult patients
      with advanced solid tumors will be recruited.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse Events(Safety)
time frame: up to 96 weeks
description: All the local reactions, systemic reactions, adverse events and serious adverse events of all the patients will be collected from the informed consent to the end of the study.
measure: Incidence of Treatment-Emergent Adverse Events(Safety)
time frame: up to 96 weeks
description: All the local reactions, systemic reactions, adverse events and serious adverse events of all the patients will be collected from the the informed consent to the end of the study.
measure: Disease Control Rate (DCR)
time frame: up to 96 weeks
description: Disease control rate is defined as the number of patients with a best overall response of complete response (CR), partial response (PR), or stable disease (SD) based on RESIST v1.1 criteria
measure: Progression-Free Survival (PFS)
time frame: up to 96 weeks
description: The length of time from enrollment until the time of progression of disease
measure: Overall Survival (OS)
time frame: up to 96 weeks
description: From enrollment to death of patients
measure: Time to recurrence (TTR)
time frame: up to 96 weeks
description: the period of time from signing of the ICF by the patient to progression of tumor
measure: time to progression(TTP)
time frame: up to 96 weeks
description: Time from the first successful apheresis to the first progression of the tumor.
measure: Objective response rate
time frame: up to 96 weeks
description: The percentage of subjects with PR or CR.
arm group label: MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody
arm group type: Experimental
description: Group 1: MASCT-I alone;
Group 2: Advanced urothelial carcinoma and cholangiocarcinoma treatment with MASCT-I alone,Advanced soft tissue sarcoma and osteosarcoma treatment with MASCT-I alone or combination with ifosfamide. In the event of disease progression, treatment with MASCT-I +PD1 antibody;
Group 3: Advanced metastatic or recurrent urothelial carcinoma, soft tissue sarcoma/osteosarcoma, and cholangiocarcinoma that progressed after first line chemotherapy were treated with MASCT-I combined with PD1 antibody;
Group 4: Recurrent metastatic solid tumors that had failed previous treatment with PD1 antibody were treated with MASCT-I + PD1 antibody;
Group 5: Untreated advanced soft tissue sarcom treatment with MASCT-I+AI (Adriamycin+ifosfamide);
Group 6: Untreated advanced urothelial carcinoma treatment with MASCT-I+GP/GC(Gemcitabine+cisplatin/ Gemcitabine+carboplatin);
intervention type: Biological
intervention name: MASCT-I
description: The final products of MASCT-I technology are dendritic cells (DC) and effector T cells
arm group label: MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody
intervention type: Drug
intervention name: Ifosfamide
description: 2g/m2/d, intravenous drip for 30min. Administration is conducted for continuous 5 days. After 4 weeks, the above cycle is repeated for 6 continuous cycles
arm group label: MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody
intervention type: Drug
intervention name: PD1 antibody
description: 200 mg/every two weeks ,four weeks is a cycle. Subjects were treated with MASCT-I combined with PD1 antibody until disease progression, MASCT-I intolerance or study completion. If PD1 antibody intolerance occurs, MASCT-I therapy alone will continue. MASCT-I and PD1 antibody are adminnistered according to their respective drug cycle without interfering with each other.
arm group label: MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody
intervention type: Drug
intervention name: Adriamycin
description: 60mg/m2, from the first day of each cycle, it is used for 1-2 days, intravenous drip. Repeat the above cycle after 4 weeks, no more than 8 cycles
arm group label: MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody
intervention type: Drug
intervention name: Gemcitabine
description: 1000 mg/m2, Intravenous drip for about 30 min, used on the first and eighth days of each cycle, and every 3-4 weeks as a cycle
arm group label: MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody
intervention type: Drug
intervention name: Cisplatin
description: 70mg/m2, Use on the first day of each chemotherapy cycle, intravenous drip for 30-120 min, and every 3-4 weeks as a cycle;
arm group label: MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody
intervention type: Drug
intervention name: Carboplatin
description: 5mg/ml/min, Use it on the first day of each chemotherapy cycle, intravenous drip for 30 minutes, and every 3-4 weeks as a cycle
arm group label: MASCT-I alone or in combination with chemical drugs or in combination with PD-1 antibody
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Ruihua Xu, Doctor
role: Principal Investigator
affiliation: Sun Yat-sen University
last name: Xuemin Rao
phone: 021-61049928
email: raoxuemin@shhryz.com
last name: Fendi Yang
email: yangfendi@shhryz.com
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Completed
country: China
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Carboplatin
mesh term: Gemcitabine
mesh term: Doxorubicin
mesh term: Liposomal doxorubicin
mesh term: Ifosfamide
mesh term: Antibodies
sharing ipd: Undecided