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

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)

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 Overview

• Status: Terminated
• Conditions: Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)
• Intervention / Treatment: Drug: TQB2450

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijin, Beijing, China, 100191
      • Peking University Third Hospital
    • Beijin, Beijing, China, 100730
      • Peking Hospital
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
    • Beijing, Beijing, China, 100071
      • Fifth Medical Center of the Chinese People's Liberation Army General Hospital
    • Beijing, Beijing, China, 100083
      • Peking Union Medical College Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Union Medical College Hospital Affiliated to Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center
  • Heilongjiang
    • Ha'erbin, Heilongjiang, China, 150081
      • Cancer Hospital Affiliated to Harbin Medical University
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Cancer Hospital
    • Zhengzhou, Henan, China, 450003
      • Henan People's Hospital
  • Hunan
    • Changsha, Hunan, China, 410006
      • Hunan Canser Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • First Hospital of Jilin University
  • Liaoning
    • Shenyang, Liaoning, China, 110001
      • First Affiliated Hospital of China Medical University
  • Shandong
    • Jinan, Shandong, China, 250000
      • Qilu Hospital of Shandong University
    • Qingdao, Shandong, China, 266005
      • Affiliated Hospital of Qingdao University
  • Shanghai
    • Shanghai, Shanghai, China, 200065
      • Shanghai Tongji Hospital
    • Shanghai, Shanghai, China, 200065
      • Shanghai Tumor Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Tumor Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Percentage of subjects achieving complete response (CR) and partial response (PR).	up to 96 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response (DOR)	DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.	up to 96 weeks
Progression-Free Survival (PFS)	PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.	up to 96 weeks
Disease Control Rate (DCR)	Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD).	up to 24 months
Time to Response (TTR)	TTR defined as time from the first dose to the first assessment of PR or CR.	up to 24 months
Overall Survival (OS)	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.	up to 24 months

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2019
• Primary Completion (Actual): January 21, 2021
• Study Completion (Actual): January 21, 2021

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: June 27, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell
• Other Study ID Numbers: TQB2450-II-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No