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

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)
Overall Status
Terminated
CT.gov ID
NCT04002622
Collaborator
(none)
1
Enrollment
18
Locations
1
Arm
17.5
Actual Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Aug 6, 2019
Actual Primary Completion Date :
Jan 21, 2021
Actual Study Completion Date :
Jan 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) [up to 96 weeks]

    Percentage of subjects achieving complete response (CR) and partial response (PR).

Secondary Outcome Measures

  1. Progression-Free Survival (PFS) [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) [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) [up to 24 months]

    Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).

  4. Time to Response (TTR) [up to 24 months]

    TTR defined as time from the first dose to the first assessment of PR or CR.

  5. Overall Survival (OS) [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

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Histologically confirmed relapsed or refractory primary mediastinal large B-cell lymphoma.

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

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

  3. Screening laboratory values must meet the following criteria:hemoglobin ≥ 80 g/L; neutrophils ≥ 1.5*109/L; platelets ≥ 100 x 109/ L.

  4. Understood and signed an informed consent form.

Exclusion Criteria:
    1. Hypersensitivity to recombinant humanized anti-PD-1 monoclonal Abm or its components.

  1. 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.

  2. 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.

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

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

  5. 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.

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

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

  8. 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.

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

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

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

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

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

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

  15. 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

Site City State Country Postal Code
1 Peking University First Hospital Beijing Beijing China 100034
2 Fifth Medical Center of the Chinese People's Liberation Army General Hospital Beijing Beijing China 100071
3 Peking Union Medical College Hospital Beijing Beijing China 100083
4 Peking University Third Hospital Beijin Beijing China 100191
5 Peking Hospital Beijin Beijing China 100730
6 Union Medical College Hospital Affiliated to Fujian Medical University Fuzhou Fujian China 350000
7 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060
8 Cancer Hospital Affiliated to Harbin Medical University Ha'erbin Heilongjiang China 150081
9 Henan Cancer Hospital Zhengzhou Henan China 450003
10 Henan People's Hospital Zhengzhou Henan China 450003
11 Hunan Canser Hospital Changsha Hunan China 410006
12 First Hospital of Jilin University Changchun Jilin China 130021
13 First Affiliated Hospital of China Medical University Shenyang Liaoning China 110001
14 Qilu Hospital of Shandong University Jinan Shandong China 250000
15 Affiliated Hospital of Qingdao University Qingdao Shandong China 266005
16 Shanghai Tongji Hospital Shanghai Shanghai China 200065
17 Shanghai Tumor Hospital Shanghai Shanghai China 200065
18 Zhejiang Tumor Hospital Hangzhou Zhejiang China 310022

Sponsors and Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04002622
Other Study ID Numbers:
  • TQB2450-II-02
First Posted:
Jun 28, 2019
Last Update Posted:
Jan 25, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell

Study Results

No Results Posted as of Jan 25, 2021