Condition or disease | Intervention/treatment | Phase |
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Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL) | Drug: TQB2450 | Phase 2 |
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 |
Arm | Intervention/treatment |
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Experimental: TQB2450
TQB2450 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle.
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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.
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
Tracking Information | |||||
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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 |
Objective Response Rate (ORR) [ Time Frame: up to 96 weeks ] Percentage of subjects achieving complete response (CR) and partial response (PR).
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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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 |
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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.
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Study Arms ICMJE | Experimental: TQB2450
TQB2450 1200 milligrams (mg) administered intravenously (IV) on Day 1 of each 21-day cycle.
Intervention: Drug: TQB2450
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
1 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |