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出境医 / 临床实验 / Study of TQB2450 Injection in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma

Study of TQB2450 Injection in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma

Study Description
Brief Summary:
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL) Drug: TQB2450 Phase 2

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Open, Single-arm Study of TQB2450 Injection (PD-L1 Antibody) in Subjects With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)
Actual Study Start Date : August 6, 2019
Actual Primary Completion Date : January 21, 2021
Actual Study Completion Date : January 21, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: TQB2450
TQB2450 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle.
Drug: TQB2450
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

Outcome Measures
Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 96 weeks ]
    Percentage of subjects achieving complete response (CR) and partial response (PR).


Secondary Outcome Measures :
  1. Progression-Free Survival (PFS) [ Time Frame: up to 96 weeks ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

  2. Duration of Response (DOR) [ Time Frame: up to 96 weeks ]
    DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

  3. Disease Control Rate (DCR) [ Time Frame: up to 24 months ]
    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

  4. Time to Response (TTR) [ Time Frame: up to 24 months ]
    TTR defined as time from the first dose to the first assessment of PR or CR.

  5. Overall Survival (OS) [ Time Frame: up to 24 months ]
    OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Histologically confirmed relapsed or refractory primary mediastinal large B-cell lymphoma.

    2. 18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy > 3 months.

    3. At least one measurable lesion. 4. Left ventricular ejection fraction (LVEF) measured by the cardiac echocardiography ≥ 50%.

    5. Screening laboratory values must meet the following criteria:hemoglobin ≥ 80 g/L; neutrophils ≥ 1.5*10^9/L; platelets ≥ 100 x 10^9/ L.

    6. Understood and signed an informed consent form.

Exclusion Criteria:

  • 1. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components.

    2. Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

    3. Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks.

    4. Has received emergency cytoreductive surgery to control tumors. 5. Has received allogeneic hematopoietic stem cell transplantation within the last 5 years.

    6. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.

    7. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include basal cell skin cancer, squamous cell carcinoma of skin, melanoma skin and cancer carcinoma in situ of the cervix.

    8. Has definite central nervous system (CNS) infiltration of lymphoma, including brain parenchyma, meningeal invasion or spinal cord compression.

    9. Has any active autoimmune disease or a history of autoimmune disease. 10. Has serious or uncontrolled diseases such as history of chronic heart failure.

    11. Has any active autoimmune disease or a history of autoimmune disease. 12. Has received blood transfusion, erythropoietin granulocyte colony stimulating factor(G -CSF),or Granulocyte macrophage colony stimulating factor(GM-CSF) within 4 weeks before the first dose.

    13. Has vaccinated with vaccines or attenuated vaccines within 4 weeks before the first dose.

    14. Has received surgery, or unhealed wounds within 4 weeks before the first dose.

    15. Has Hepatic, renal, blood coagulation dysfunction. 16. Has interstitial lung disease or non-infectious pneumonia and present residual lesions.

    17. Has received systemic treatment for active infection before the first dose.

    18. Has active or latent tuberculosis. 19. Hepatitis B virus surface antigen (HBsAg) positive, and hepatitis B virus DNA copy number > upper limit of normal.

    20. Human immunodeficiency virus antibody positive , hepatitis C antibody (HCV-Ab) and hepatitis C virus DNA copy number > upper limit of normal.

    21. Breastfeeding or pregnant women. 22. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Contacts and Locations

Locations
Show Show 18 study locations
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date January 25, 2021
Actual Study Start Date  ICMJE August 6, 2019
Actual Primary Completion Date January 21, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
Objective Response Rate (ORR) [ Time Frame: up to 96 weeks ]
Percentage of subjects achieving complete response (CR) and partial response (PR).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • Progression-Free Survival (PFS) [ Time Frame: up to 96 weeks ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
  • Duration of Response (DOR) [ Time Frame: up to 96 weeks ]
    DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
  • Disease Control Rate (DCR) [ Time Frame: up to 24 months ]
    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).
  • Time to Response (TTR) [ Time Frame: up to 24 months ]
    TTR defined as time from the first dose to the first assessment of PR or CR.
  • Overall Survival (OS) [ Time Frame: up to 24 months ]
    OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of TQB2450 Injection in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma
Official Title  ICMJE A Phase II, Multicenter, Open, Single-arm Study of TQB2450 Injection (PD-L1 Antibody) in Subjects With Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)
Brief Summary TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)
Intervention  ICMJE Drug: TQB2450
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
Study Arms  ICMJE Experimental: TQB2450
TQB2450 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle.
Intervention: Drug: TQB2450
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 21, 2021)
1
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2019)
52
Actual Study Completion Date  ICMJE January 21, 2021
Actual Primary Completion Date January 21, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Histologically confirmed relapsed or refractory primary mediastinal large B-cell lymphoma.

    2. 18 and 75 years; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy > 3 months.

    3. At least one measurable lesion. 4. Left ventricular ejection fraction (LVEF) measured by the cardiac echocardiography ≥ 50%.

    5. Screening laboratory values must meet the following criteria:hemoglobin ≥ 80 g/L; neutrophils ≥ 1.5*10^9/L; platelets ≥ 100 x 10^9/ L.

    6. Understood and signed an informed consent form.

Exclusion Criteria:

  • 1. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components.

    2. Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody ,or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

    3. Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks.

    4. Has received emergency cytoreductive surgery to control tumors. 5. Has received allogeneic hematopoietic stem cell transplantation within the last 5 years.

    6. Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.

    7. Has diagnosed and/or treated additional malignancy within 5 years prior to randomization. Exceptions include basal cell skin cancer, squamous cell carcinoma of skin, melanoma skin and cancer carcinoma in situ of the cervix.

    8. Has definite central nervous system (CNS) infiltration of lymphoma, including brain parenchyma, meningeal invasion or spinal cord compression.

    9. Has any active autoimmune disease or a history of autoimmune disease. 10. Has serious or uncontrolled diseases such as history of chronic heart failure.

    11. Has any active autoimmune disease or a history of autoimmune disease. 12. Has received blood transfusion, erythropoietin granulocyte colony stimulating factor(G -CSF),or Granulocyte macrophage colony stimulating factor(GM-CSF) within 4 weeks before the first dose.

    13. Has vaccinated with vaccines or attenuated vaccines within 4 weeks before the first dose.

    14. Has received surgery, or unhealed wounds within 4 weeks before the first dose.

    15. Has Hepatic, renal, blood coagulation dysfunction. 16. Has interstitial lung disease or non-infectious pneumonia and present residual lesions.

    17. Has received systemic treatment for active infection before the first dose.

    18. Has active or latent tuberculosis. 19. Hepatitis B virus surface antigen (HBsAg) positive, and hepatitis B virus DNA copy number > upper limit of normal.

    20. Human immunodeficiency virus antibody positive , hepatitis C antibody (HCV-Ab) and hepatitis C virus DNA copy number > upper limit of normal.

    21. Breastfeeding or pregnant women. 22. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04002622
Other Study ID Numbers  ICMJE TQB2450-II-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study Sponsor  ICMJE Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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