Clinical trial NCT04002622: Study of TQB2450 Injection in Subjects With Relapsed or Refractory Primary Mediastinal Large B-cell Lymphoma
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Relapsed or Refractory Primary Mediastinal B-cell Lymphoma (rrPMBCL)
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-06-28
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 96 weeks
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: up to 96 weeks
measure: Duration of Response (DOR)
timeFrame: up to 96 weeks
measure: Disease Control Rate (DCR)
timeFrame: up to 24 months
measure: Time to Response (TTR)
timeFrame: up to 24 months
measure: Overall Survival (OS)
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Fifth Medical Center of the Chinese People's Liberation Army General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijin
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijin
country: China
facility: Peking Hospital
state: Beijing
city: Fuzhou
country: China
facility: Union Medical College Hospital Affiliated to Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Ha'erbin
country: China
facility: Cancer Hospital Affiliated to Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan People's Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Canser Hospital
state: Hunan
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: First Affiliated Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tumor Hospital
state: Shanghai
city: Hangzhou
country: China
facility: Zhejiang Tumor Hospital
state: Zhejiang
Study officials:
References: